Home NDC 75904-3246 CalmaFX
Product NDC 75904-3246
11-digit product format 759043246
Labeler code 75904
Product ID 75904-3246_5ba9ed70-fdbd-435c-ae6f-b6f14e573bca
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, CALAMINE, ZINC OXIDE
Dosage form OINTMENT
Route TOPICAL
Labeler First Choice Medical Supply
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2011-02-28
Marketing end 0000-00-00
Substance MENTHOL; FERRIC OXIDE RED; ZINC OXIDE
Active strength 5 mg/g; mg/g; mg/g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 75904-3246 I Inactivated by FDA 2026-07-31 excluded package package 75904-3246 75904-3246-0 I Inactivated by FDA 2026-07-31 excluded package package 75904-3246 75904-3246-3 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Astringent CALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATE Granulation Technology, Inc. 1c2bf19c-2f32-4a22-a371-16cc744dce76 2025-06-12 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. 91f24a0c-276f-4962-8da8-462b1f42040e 2019-05-17 Warnings Exact identifier Eczema Care Moisturizing 3 oz. COLLOIDAL OATMEAL Rejoice International Inc. 83967d26-159a-e95c-e053-2991aa0af53a 2019-03-08 Warnings Exact identifier Oatmeal Skin Relief Calming . 8oz DIMETHICONE Rejoice International Inc. 8384dc52-ba36-da3d-e053-2a91aa0a4f40 2019-03-07 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. b8832ee7-3e13-456b-b301-dad7473a032b 2019-02-04 Warnings Exact identifier BURTS BEES BABY BEE DIAPER RASH ZINC OXIDE BURT'S BEES, INC. 168b31b1-9260-61f8-e054-00144ff8d46c 2018-12-21 Warnings Exact identifier Balmex Diaper Rash ZINC OXIDE Randob Labs,Ltd. f202dd0e-7c61-4ea1-a5f6-e90898366ba3 2018-11-13 Warnings Exact identifier BALMEX ADULT CARE RASH ZINC OXIDE Randob Labs,Ltd. 9443a987-c7b2-4b0d-a9dc-02233135af81 2018-11-13 Warnings Exact identifier BALMEX MULTI-PURPOSE PETROLATUM Randob Labs,Ltd. 83a9ba1a-b708-47e2-a4a3-ef847e1bb792 2018-11-13 Warnings Exact identifier Natures Choice Vitamins A and D A AND D OINTMENT Unipack, Inc. 17861122-2231-4a54-b3d8-894153c708d7 2018-01-15 Warnings Exact identifier MG217 Eczema Face COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5f10697e-7f0c-f2b7-e053-2991aa0aabde 2017-11-30 Warnings Exact identifier MG217 Baby Eczema COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5d65052d-2972-544d-e053-2a91aa0afa3e 2017-11-28 Warnings Exact identifier Vitamin A and D LANOLIN AND PETROLATUM Family Dollar Services Inc 4826b36d-3326-4f5c-8b22-c5ff79e55062 2017-11-08 Warnings Exact identifier TriCalm Hydrogel ALUMINUM ACETATE Modular Thermal Technologies LLC Dba Life Wear Technologies 5cb42ffb-3655-4c38-bf84-1cf33c82df10 2017-03-23 Warnings Exact identifier CVS Health Diaper Rash ZINC OXIDE CVS Health 12f786a0-0960-4b98-9f0b-dcf3725a9866 2017-03-20 Warnings Exact identifier ARGAN AIR WATER BANG ESSENCE DIMETHICONE Pioom Cosmetic Co.,ltd 34e79668-0710-5753-e054-00144ff88e88 2016-06-08 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75904-3246-0 CalmaFXMoisture Barrier 113 g in 1 TUBE OINTMENT 113 4 75904-3246-3 CalmaFXMoisture Barrier 5 g in 1 POUCH OINTMENT 5 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded FERRIC OXIDE RED ACTIVE INGREDIENT 1K09F3G675 CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 MENTHOL ACTIVE INGREDIENT L7T10EIP3A CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 ZINC OXIDE ACTIVE INGREDIENT SOI2LOH54Z CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 FERRIC OXIDE RED ACTIVE MOIETY 1K09F3G675 CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 MENTHOL ACTIVE MOIETY L7T10EIP3A CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 ZINC OXIDE ACTIVE MOIETY SOI2LOH54Z CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 LANOLIN INACTIVE INGREDIENT 7EV65EAW6H CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 MINERAL OIL INACTIVE INGREDIENT T5L8T28FGP CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 SODIUM BORATE INACTIVE INGREDIENT 91MBZ8H3QO CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 WATER INACTIVE INGREDIENT 059QF0KO0R CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 YELLOW WAX INACTIVE INGREDIENT 2ZA36H0S2V CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75904-3246 CALMAFX MOISTURE BARRIER (MENTHOL, CALAMINE, ZINC OXIDE) OINTMENT [FIRST CHOICE MEDICAL SUPPLY] 4 Legacy NDC, 2 package rows 20130325_7b52374e-1119-4145-b87b-96b7212fdc3e.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 75904-3246-0 75904324600 113 g in 1 TUBE 113 g Historical 75904-3246-3 75904324603 5 g in 1 POUCH 5 g Historical