Application 018683

Type: NDA
Sponsor: MAYER LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TODAY	NONOXYNOL-9	SPONGE;VAGINAL	1GM	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N018683-001	TODAY	NONOXYNOL-9	1GM	SPONGE / VAGINAL		RLD	1983-04-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD, RS	1983-04-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD, RS	1983-04-01	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD, RS	1983-04-01	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD, RS	1983-04-01	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N018683-001	TODAY	1GM	SPONGE / VAGINAL	RLD	1983-04-01	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VCF CONTRACEPTIVE	NONOXYNOL-9	APOTHECUS PHARMACEUTICAL CORP.	92f8eee8-2456-4baf-a85e-1335c80d7fcd	2025-12-12	Warnings	Name fallback generic name: NONOXYNOL-9
VCF CONTRACEPTIVE PRE-FILLED APPLICATORS	NONOXYNOL-9	APOTHECUS PHARMACEUTICAL CORP	34be97cd-3646-427d-8112-ba0030ff8d88	2025-12-12	Warnings	Name fallback generic name: NONOXYNOL-9

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
44376-100	Today Vaginal Contraceptive	Nonoxynol-9	Mayer Laboratories, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
15089	SUPPL	2010-06-02
33556	SUPPL	2005-04-29
1022	SUPPL	2005-04-28
1021	SUPPL	2004-11-08