FDA.reportPublic FDA data

Major Vitamin A and D

Product NDC
0904-5843
11-digit product format
009045843
Labeler code
0904
Product ID
0904-5843_1874b9fb-ea3f-4444-a4b7-b20366a2a97a
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum and Lanolin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Major Pharmaceuticals
Application
part347
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2007-09-01
Marketing end
0000-00-00
Substance
PETROLATUM; LANOLIN
Active strength
53 mL/100g; mL/100g
NDC exclude flag
E
Listing certified through
2018-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-5843DDiscontinued by firm2026-07-31
excluded packagepackage0904-58430904-5843-27DDiscontinued by firm2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AstringentCALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATEGranulation Technology, Inc.1c2bf19c-2f32-4a22-a371-16cc744dce762025-06-12WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.91f24a0c-276f-4962-8da8-462b1f42040e2019-05-17WarningsExact identifier
Eczema Care Moisturizing 3 oz.COLLOIDAL OATMEALRejoice International Inc.83967d26-159a-e95c-e053-2991aa0af53a2019-03-08WarningsExact identifier
Oatmeal Skin Relief Calming . 8ozDIMETHICONERejoice International Inc.8384dc52-ba36-da3d-e053-2a91aa0a4f402019-03-07WarningsExact identifier
PetrolatumPETROLATUMGreenbrier International, Inc.b8832ee7-3e13-456b-b301-dad7473a032b2019-02-04WarningsExact identifier
BURTS BEES BABY BEE DIAPER RASHZINC OXIDEBURT'S BEES, INC.168b31b1-9260-61f8-e054-00144ff8d46c2018-12-21WarningsExact identifier
Balmex Diaper RashZINC OXIDERandob Labs,Ltd.f202dd0e-7c61-4ea1-a5f6-e90898366ba32018-11-13WarningsExact identifier
BALMEX ADULT CARE RASHZINC OXIDERandob Labs,Ltd.9443a987-c7b2-4b0d-a9dc-02233135af812018-11-13WarningsExact identifier
BALMEX MULTI-PURPOSEPETROLATUMRandob Labs,Ltd.83a9ba1a-b708-47e2-a4a3-ef847e1bb7922018-11-13WarningsExact identifier
Natures Choice Vitamins A and DA AND D OINTMENTUnipack, Inc.17861122-2231-4a54-b3d8-894153c708d72018-01-15WarningsExact identifier
MG217 Eczema FaceCOLLOIDAL OATMEALWisconsin Pharmacal Company5f10697e-7f0c-f2b7-e053-2991aa0aabde2017-11-30WarningsExact identifier
MG217 Baby EczemaCOLLOIDAL OATMEALWisconsin Pharmacal Company5d65052d-2972-544d-e053-2a91aa0afa3e2017-11-28WarningsExact identifier
Vitamin A and DLANOLIN AND PETROLATUMFamily Dollar Services Inc4826b36d-3326-4f5c-8b22-c5ff79e550622017-11-08WarningsExact identifier
TriCalm HydrogelALUMINUM ACETATEModular Thermal Technologies LLC Dba Life Wear Technologies5cb42ffb-3655-4c38-bf84-1cf33c82df102017-03-23WarningsExact identifier
CVS Health Diaper RashZINC OXIDECVS Health12f786a0-0960-4b98-9f0b-dcf3725a98662017-03-20WarningsExact identifier
ARGAN AIR WATER BANG ESSENCEDIMETHICONEPioom Cosmetic Co.,ltd34e79668-0710-5753-e054-00144ff88e882016-06-08WarningsExact 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.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5843-27GM - Gram0904-584323f489c1-5348-48c6-bce4-de88554842d012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LanolinACTIVE INGREDIENT7EV65EAW6HMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
PetrolatumACTIVE INGREDIENT4T6H12BN9UMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
LanolinACTIVE MOIETY7EV65EAW6HMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
PetrolatumACTIVE MOIETY4T6H12BN9UMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
Cod Liver OilINACTIVE INGREDIENTBBL281NWFGMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVPMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
Microcrystalline WaxINACTIVE INGREDIENTXOF597Q3KYMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZEMAJOR VITAMIN A AND D SKIN PROTECTANT (PETROLATUM AND LANOLIN) OINTMENT [MAJOR PHARMACEUTICALS]1