Gynol II

Product NDC: 34362-0302
11-digit product format: 343620302
Labeler code: 34362
Product ID: 34362-0302_3cadc6ea-8dc2-4fa2-8fdf-aebfe1378941
Type: HUMAN OTC DRUG
Nonproprietary name: Nonoxynol
Dosage form: GEL
Route: VAGINAL
Labeler: Caldwell Consumer Health LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-05-01
Marketing end: 0000-00-00
Substance: NONOXYNOL-9
Active strength: 3 g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	34362-0302		I	Inactivated by FDA		2026-08-17
excluded package	package	34362-0302	34362-0302-5	I	Inactivated by FDA		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 38 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	34362-0302-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	34362-0302-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	34362-0302-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	34362-0302-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	34362-0302-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	34362-0302-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	34362-0302-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	34362-0302-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	34362-0302-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	34362-0302-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	34362-0302-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	34362-0302-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	34362-0302-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	34362-0302-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	34362-0302-5	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	34362-0302-5	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	34362-0302-5	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	34362-0302-5	`bd6a592717d7…`	`303034d00443…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	34362-0302-5	`9bebd1f3094a…`	`5416666fcb17…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
34362-0302-5	2022-01-28	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts
34362-0302-5	2020-12-01	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts
34362-0302-5	2020-01-31	C162847	48780-1	9d75b9d0-30a9-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
34362-0302-1	Gynol IIExtra Strength	81 g in 1 BOTTLE, WITH APPLICATOR	GEL	81		7
34362-0302-5	Gynol IIExtra Strength	1 in 1 CARTON	GEL	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
34362-0302-1	GM - Gram	34362-0302	67da3f90-9ddf-4646-807a-abbb4d77ffef	1	2018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NONOXYNOL-9	ACTIVE INGREDIENT	48Q180SH9T	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
NONOXYNOL-9	ACTIVE MOIETY	48Q180SH9T	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
LACTIC ACID	INACTIVE INGREDIENT	33X04XA5AT	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
SORBITOL	INACTIVE INGREDIENT	506T60A25R	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
34362-0302	GYNOL II EXTRA STRENGTH (NONOXYNOL) GEL [CALDWELL CONSUMER HEALTH LLC]	7	Legacy NDC, 2 package rows	20201203_eaf86a36-0573-4c39-9324-88919c4d009b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
48Q180SH9T	NONOXYNOL-9	26027-38-3	NONOXYNOL-9

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1250090	GYNOL II Extra Strength 3 % Vaginal Gel	PSN	eaf86a36-0573-4c39-9324-88919c4d009b	7
312029	nonoxynol-9 3 % Vaginal Gel	PSN	eaf86a36-0573-4c39-9324-88919c4d009b	7
1250090	nonoxynol-9 0.03 MG/MG Vaginal Gel [Gynol II]	SBD	eaf86a36-0573-4c39-9324-88919c4d009b	7
312029	nonoxynol-9 0.03 MG/MG Vaginal Gel	SCD	eaf86a36-0573-4c39-9324-88919c4d009b	7
1250090	Gynol II 0.03 MG/MG Vaginal Gel	SY	eaf86a36-0573-4c39-9324-88919c4d009b	7
1250090	Gynol II Extra Strength 3 % Vaginal Gel	SY	eaf86a36-0573-4c39-9324-88919c4d009b	7
312029	nonoxynol-9 3 % Vaginal Gel	SY	eaf86a36-0573-4c39-9324-88919c4d009b	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
34362-0302-1	34362030201	81 g in 1 BOTTLE, WITH APPLICATOR	81 g					Historical
34362-0302-5	34362030205	1 BOTTLE, WITH APPLICATOR in 1 CARTON (34362-0302-5) > 81 g in 1 BOTTLE, WITH APPLICATOR (34362-0302-1)		2020-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Caldwell Consumer Health LLC \| Lornamead \| DPT Laboratories	2020-12-01	HUMAN OTC DRUG LABEL	7