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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66854-003-01GYNOX-SOFT210 mL in 1 BOTTLEEMULSION2101
66854-003-02GYNOX-SOFT250 mL in 1 BOTTLEEMULSION2501
66854-003-03GYNOX-SOFT260 mL in 1 BOTTLEEMULSION2601
66854-003-04GYNOX-SOFT270 mL in 1 BOTTLEEMULSION2701
66854-003-05GYNOX-SOFT400 mL in 1 BOTTLEEMULSION4001
66854-003-06GYNOX-SOFT515 mL in 1 BOTTLEEMULSION5151
66854-003-07GYNOX-SOFT1000 mL in 1 BOTTLEEMULSION10001
66854-003-08GYNOX-SOFT12 mL in 1 BAGEMULSION121
66854-003-09GYNOX-SOFT30 in 1 BOXEMULSION301
66854-003-10GYNOX-SOFT500 mL in 1 BOTTLEEMULSION5001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORIC ACIDACTIVE INGREDIENTR57ZHV85D4GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
BORIC ACIDACTIVE MOIETYR57ZHV85D4GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
CALENDULA OFFICINALIS FLOWERINACTIVE INGREDIENTP0M7O4Y7YDGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225BGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
DECYL GLUCOSIDEINACTIVE INGREDIENTZ17H97EA6YGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21WGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
PEG-120 METHYL GLUCOSE DIOLEATEINACTIVE INGREDIENTYM0K64F20VGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
SODIUM LAUROYL LACTYLATEINACTIVE INGREDIENT7243K85WFOGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1
WATERINACTIVE INGREDIENT059QF0KO0RGYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66854-003GYNOX-SOFT (BORIC ACID) EMULSION [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]1Legacy NDC, 10 package rows20120630_22e79312-b49c-4392-8a7a-a9bd04e9e2df.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
66854-003-0166854000301210 mL in 1 BOTTLE210 mlHistorical
66854-003-0266854000302250 mL in 1 BOTTLE250 mlHistorical
66854-003-0366854000303260 mL in 1 BOTTLE260 mlHistorical
66854-003-0466854000304270 mL in 1 BOTTLE270 mlHistorical
66854-003-0566854000305400 mL in 1 BOTTLE400 mlHistorical
66854-003-0666854000306515 mL in 1 BOTTLE515 mlHistorical
66854-003-07668540003071000 mL in 1 BOTTLE1000 mlHistorical
66854-003-086685400030812 mL in 1 BAG12 mlHistorical
66854-003-096685400030930 in 1 BOXHistorical
66854-003-1066854000310500 mL in 1 BOTTLE500 mlHistorical