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 8 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
WALGREENS EARACHE DROPSBELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFURWalgreen Companyc573dc3c-992e-604d-e053-2995a90a0ff42025-11-19WarningsExact identifier
unii: FGL3685T2X
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.1c0bbcb7-5ed6-4ee7-b297-080d3359474e2025-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
miranda castros HEALING FOR INSECT BITES AND STINGSCALENDULA OFFICINALIS, CALADIUM SEGUINUM, LEDUM PALUSTRE, NATRUM MURIATICUM, PLANTAGO MAJOR, STAPHYSAGRIA, URTICA URENSMIRANDA CASTRO'S SHOP, LLC1f99d32e-2394-411a-e063-6294a90ac4542025-10-23WarningsExact identifier
unii: P0M7O4Y7YD

Reported adverse events (FAERS/openFDA)#

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