GYNOX-SOFT

Product NDC: 66854-003
11-digit product format: 668540003
Labeler code: 66854
Product ID: 66854-003_63764ca7-1280-4fec-a562-b73eb70644b3
Type: HUMAN OTC DRUG
Nonproprietary name: BORIC ACID
Dosage form: EMULSION
Route: TOPICAL
Labeler: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2012-06-30
Marketing end: 0000-00-00
Substance: BORIC ACID
Active strength: 7 mg/100mL
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66854-003		I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-01	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-02	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-03	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-04	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-05	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-06	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-07	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-09	I	Inactivated by FDA	2026-08-11
excluded package	package	66854-003	66854-003-10	I	Inactivated by FDA	2026-08-11

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 4 · 220 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	66854-003-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-003-05	`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	66854-003-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-003-05	`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	66854-003-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-003-05	`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	66854-003-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-003-05	`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	66854-003-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-003-05	`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	66854-003-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-003-05	`cdf11ea48f46…`	`ba0047e9e063…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
66854-003-01	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-02	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-03	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-04	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-05	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-06	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-07	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-09	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene
66854-003-10	GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66854-003-01	GYNOX-SOFT	210 mL in 1 BOTTLE	EMULSION	210	1
66854-003-02	GYNOX-SOFT	250 mL in 1 BOTTLE	EMULSION	250	1
66854-003-03	GYNOX-SOFT	260 mL in 1 BOTTLE	EMULSION	260	1
66854-003-04	GYNOX-SOFT	270 mL in 1 BOTTLE	EMULSION	270	1
66854-003-05	GYNOX-SOFT	400 mL in 1 BOTTLE	EMULSION	400	1
66854-003-06	GYNOX-SOFT	515 mL in 1 BOTTLE	EMULSION	515	1
66854-003-07	GYNOX-SOFT	1000 mL in 1 BOTTLE	EMULSION	1000	1
66854-003-08	GYNOX-SOFT	12 mL in 1 BAG	EMULSION	12	1
66854-003-09	GYNOX-SOFT	30 in 1 BOX	EMULSION	30	1
66854-003-10	GYNOX-SOFT	500 mL in 1 BOTTLE	EMULSION	500	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BORIC ACID	ACTIVE INGREDIENT	R57ZHV85D4	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
BORIC ACID	ACTIVE MOIETY	R57ZHV85D4	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CALENDULA OFFICINALIS FLOWER	INACTIVE INGREDIENT	P0M7O4Y7YD	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
COCO GLUCOSIDE	INACTIVE INGREDIENT	ICS790225B	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
DECYL GLUCOSIDE	INACTIVE INGREDIENT	Z17H97EA6Y	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PEG-120 METHYL GLUCOSE DIOLEATE	INACTIVE INGREDIENT	YM0K64F20V	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-003	GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 10 package rows	20120630_22e79312-b49c-4392-8a7a-a9bd04e9e2df.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R57ZHV85D4	BORIC ACID	10043-35-3	BORIC ACID

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
66854-003-01	66854000301	210 mL in 1 BOTTLE	210 ml	Historical
66854-003-02	66854000302	250 mL in 1 BOTTLE	250 ml	Historical
66854-003-03	66854000303	260 mL in 1 BOTTLE	260 ml	Historical
66854-003-04	66854000304	270 mL in 1 BOTTLE	270 ml	Historical
66854-003-05	66854000305	400 mL in 1 BOTTLE	400 ml	Historical
66854-003-06	66854000306	515 mL in 1 BOTTLE	515 ml	Historical
66854-003-07	66854000307	1000 mL in 1 BOTTLE	1000 ml	Historical
66854-003-08	66854000308	12 mL in 1 BAG	12 ml	Historical
66854-003-09	66854000309	30 in 1 BOX		Historical
66854-003-10	66854000310	500 mL in 1 BOTTLE	500 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GYNOX-SOFT NEUTRAL, SCENTED AND TEEN, Foamy emulsion for Intimate hygiene	SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS	2012-06-07	HUMAN OTC DRUG LABEL	1