No. As of September 23, 2026 there is no FDA-approved oxytocin nasal spray in the United States. Every oxytocin product approved today is a parenteral solution. The only nasal application ever listed in Drugs@FDA is NDA 012285, Syntocinon nasal solution, and FDA withdrew its approval effective September 8, 1997.

What Drugs@FDA lists for oxytocin

A Drugs@FDA query through openFDA for oxytocin as an active ingredient returns nine applications: five carry prescription marketing status, four are discontinued.

The Pitocin file carries a labelling supplement approved 11 May 2021 and the Fresenius Kabi file one approved 20 September 2022, so both are actively maintained.

Was there ever an approved oxytocin nasal spray?

Yes, once. NDA 012285 is the only nasal oxytocin application that has ever appeared in Drugs@FDA. Its public overview page reads:

SYNTOCINON · OXYTOCIN · RTRX · 40USP UNITS/ML · SOLUTION;NASAL · DiscontinuedDrugs@FDA application overview, NDA 012285, retrieved September 23, 2026

No approval date is displayed there, and the submissions endpoint returns no records, which is the normal pattern for a pre-1982 application. The original approval date is simply not in the public record. What is documented precisely is the end of it.

What FDA said when it withdrew NDA 12-285

The withdrawal is in the Federal Register of August 7, 1997, at 62 FR 42575, "Sterling Drug, Inc., et al.; Withdrawal of Approval of 28 New Drug Applications, 9 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications", Docket No. 97N-0326. The Syntocinon nasal product appears in the notice's table, listed to Novartis Pharmaceutical Corp. of East Hanover, New Jersey. The notice explains why the applications were on the list:

The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.FDA, 62 FR 42575, August 7, 1997

And the operative sentence:

approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective September 8, 1997.FDA, 62 FR 42575, signed July 17, 1997 by Janet Woodcock, Director, Center for Drug Evaluation and Research

Intranasal oxytocin has had no effective US marketing approval since September 8, 1997.

The listing discrepancy, stated plainly

Two facts in the federal record do not obviously fit together, and it is better to show both.

Drugs@FDA today still lists NDA 012285 with sponsor "RTRX" and status "Discontinued". The 1997 notice withdrew approval of that same application number, attributing it to Novartis. Drugs@FDA retains records for withdrawn and discontinued applications, so the presence of a record is not evidence of a live approval, but the later sponsor name is not explained by the notice.

A full-text search of the Federal Register for "Syntocinon" returns exactly two documents, the 1997 notice and the 2009 notice below. Neither reinstates NDA 012285. The mechanism behind the current sponsor attribution is unresolved on the public record, so both facts stand and we assert no reconciliation.

The other withdrawals, 1996 and 2009

Two more oxytocin applications were withdrawn after the nasal one, and neither withdrawal was about the molecule failing.

The parenteral Syntocinon, NDA 18-245, went in 2009. The Federal Register of May 19, 2009, at 74 FR 23407, Docket No. FDA-2009-N-0211, lists it and states the effective date:

Dates: Effective: June 18, 2009.FDA, 74 FR 23407, May 19, 2009

The oxytocin-in-dextrose products, NDA 019-185, went earlier. The Federal Register of April 22, 2015, at 80 FR 22529, Docket No. FDA-2014-P-1896, records the sequence: approval on March 29, 1985; a letter of December 26, 1995 in which Abbott Laboratories asked for the application to be withdrawn; the withdrawal announced at 61 FR 13506 on March 27, 1996, effective April 26, 1996. Responding to a citizen petition, FDA then determined:

After considering the citizen petition and reviewing Agency records, and based on the information we have at this time, FDA has determined under Sec. 314.161 that these oxytocin drug products were not withdrawn for reasons of safety or effectiveness.FDA, 80 FR 22529, April 22, 2015

That determination is what lets a discontinued product remain a reference point rather than a prohibition. What "withdrawn" does and does not imply is covered in the FDA-approved peptides status table.

What the NDC directory shows today

FDA's National Drug Code directory, queried on September 23, 2026 for products with oxytocin as an active ingredient, returns 59 listings. None has a nasal route.

Two rows repay a second look. Every oxytocin-containing spray in the directory is an oral spray, and all three sit in the unapproved homeopathic marketing category. That phrase describes how a product was listed. It is not an approval, and it is not evidence that any oxytocin spray has been reviewed by FDA.

The other block is bulk material: 32 of the 59 listings are powders, entered as bulk ingredient, bulk ingredient for human prescription compounding, or drug for further processing. The listers include Piramal Pharma, Hemmo Pharmaceuticals, Aspen Oss, Hybio (as oxytocin acetate), Spectrum Laboratory Products, Darmerica, Letco Medical, Medisca and Professional Compounding Centers of America. Bulk active ingredient is openly listed and openly sourced, a different question from whether a finished nasal product is approved.

Where the compounding lists put oxytocin

Oxytocin is absent from the 503A bulks list at 21 CFR 216.23, absent from the 21 CFR 216.24 list of substances withdrawn or removed for reasons of safety or effectiveness, and absent from FDA's 503A Category 1, 2 and 3 nomination document as updated May 14, 2026. It does appear on 503B Category 1 in FDA's nomination list updated March 21, 2025, carrying the double asterisk that the same document defines as "Designates bulk drug substances that are components of FDA approved drugs".

The rest of that machinery is set out in 503A, 503B and research use only and in Category 1, Category 2 and the 503A bulks list. Note one contrast in the final 503B list: vasopressin was formally evaluated and not included, while oxytocin has never been adjudicated either way.

Status as of September 23, 2026

Our own oxytocin liquid spray is a 10 mL solution in the Liquid sprays category, labelled research use only. It is not an FDA-approved drug product, not the subject of any application above, and this site publishes no guidance on using it. The molecule itself, sequence, ring and mass, is covered in oxytocin and vasopressin.

Sources

• Drugs@FDA via openFDA, applications with oxytocin as an active ingredient
• Drugs@FDA application overview, NDA 012285, Syntocinon nasal solution
• 62 FR 42575, Sterling Drug, Inc., et al.; Withdrawal of Approval, August 7, 1997, GPO text
• 74 FR 23407, Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval, May 19, 2009, GPO text
• 80 FR 22529, Determination that oxytocin in 5% dextrose products were not withdrawn for safety or effectiveness, April 22, 2015, GPO text
• FDA National Drug Code directory via openFDA, oxytocin listings
• 21 CFR 216.23, bulk drug substances that may be used to compound under section 503A, eCFR
• FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503A, updated May 14, 2026
• FDA, Bulk Drug Substances Nominated for Use in Compounding Under Section 503B, updated March 21, 2025
• FDA, Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B, January 2025
• FDA, 503B bulk drug substances list
• 21 CFR Part 1308, DEA schedules of controlled substances, eCFR