NDC 66854-003-08 - GYNOX-SOFT

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
66854-003
Requested NDC
66854-003-08
Package NDCs from labels
66854-003-01, 66854-003-02, 66854-003-03, 66854-003-04, 66854-003-05, 66854-003-06, 66854-003-07, 66854-003-08, 66854-003-09, 66854-003-10
Manufacturer
SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Effective date
2012-06-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
GYNOX-SOFT - SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICSSPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS2012-06-07HUMAN OTC DRUG LABEL

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 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

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

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 7 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Foot CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480e32e4-42d1-606c-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Citrus Zest Lip BalmCALENDULA OFFICIALS FLOWERSSpry Life LLC48c02d94-faad-110c-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Free to BreatheCALENDULA, EUCALYPTUS,PEPPERMINTSpry Life LLC8d437d62-2cbc-5b17-e053-2a95a90ad5cb2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Belly BalmROSEHIP SEED OILSpry Life LLC7c03ade4-7e84-7f5e-e053-2a91aa0a6fd22025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Poison Ivy CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480ee4ba-a92c-07ee-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Dry Skin CareCALENDULA OFFICIALS FLOWERS, CHAMOLLIA RECUTITA FLOWERS, VIOLA TRICOLOR LEAF, SAMBUCUS NIGRA FLOWERS, TRIFOLIUM PRATENSE FLOWERS, ARCHILLEA MILLEFOLIUMSpry Life LLC48329ee2-d8df-2179-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: FGL3685T2X
unii: P0M7O4Y7YD
Sweet Honey Lip BalmZINC OXIDE, CALENDULA OFFICIALS FLOWERSSpry Life LLC48c1c11d-296b-5e48-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Baby BalmCALENDULA OFFICINALIS, CHAMOMILLA RECUTITA, ARCHILLEA MILLEFOLIUM, SYMPHYTUM OFFICINALIS, HELIANTHUS ANNUUSSpry Life LLC48313e43-245f-5257-e054-00144ff8d46c2025-12-15WarningsExact identifier
unii: FGL3685T2X
unii: P0M7O4Y7YD
Eczema Face and Body WashCALENDULA, YARROW, CHAMOMILE, ELDERSpry Life LLCe068aedb-04b7-1c17-e053-2995a90a4fcc2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Acne Face WashCALENDULA, YARROW, CHAMOMILESpry Life LLCdbd6d26d-ceb5-c214-e053-2a95a90a70c22025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Hydrating Face WashCALENDULASpry Life LLCe0648212-f843-902a-e053-2995a90a5e5d2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
SalvacineCALENDULA OFFICIALS, PLANTAGO MAJOR, OLEA EUROPAEA, ACHILLEA MILLEFOLIUMSpry Life LLCe76594d6-7397-5d57-e053-2a95a90a99af2025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Tattoo CareCALENDULA OFFICIALS, STELLARIA MEDIA, ST. JOHNS WORT, ROSEMARY OIL, PLANTAGO MAJOR, COMMIPHORA MYRRHA, COMFREY LEAF, SALVIA OFFICINALIS, SUNFLOWER OILSpry Life LLC480f0858-1f69-057c-e054-00144ff88e882025-12-15WarningsExact identifier
unii: P0M7O4Y7YD
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
EELHOE Tanning MistGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.32670243-957d-3a95-e063-6394a90a58932025-11-27WarningsExact identifier
unii: P0M7O4Y7YD
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact identifier
unii: FGL3685T2X
HOUKEA Rapid Mole Spot Elimination GelGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.31c7490c-bcef-5e58-e063-6394a90ac8db2025-11-27WarningsExact identifier
unii: FGL3685T2X
HOUKEA Rapid Mole Spot Elimination GelGLYCERINGuangzhou Houkea Biotechnology Co., Ltd.3b35c488-144b-bf46-e063-6394a90a08432025-11-27WarningsExact identifier
unii: FGL3685T2X
Splash Pure PFPROPYLENE GLYCOLLABORATORIOS SOPHIA, S.A. DE C.V.40ad7ae5-1f2a-e3b1-e063-6294a90a6f842025-11-26WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.