PrimaGuard

Product NDC
75904-3343
11-digit product format
759043343
Labeler code
75904
Product ID
75904-3343_7ea32c8e-f745-4325-a0c2-a891f0f7f55f
Type
HUMAN OTC DRUG
Nonproprietary name
LANOLIN
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
LANOLIN
Active strength
300 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct75904-3343IInactivated by FDA2026-07-31
excluded packagepackage75904-334375904-3343-4IInactivated by FDA2026-07-31
excluded packagepackage75904-334375904-3343-5IInactivated by FDA2026-07-31

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.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75904-3343-4PrimaGuardDaily Care Skin Protectant5 g in 1 POUCHOINTMENT52
75904-3343-5PrimaGuardDaily Care Skin Protectant113 g in 1 TUBEOINTMENT1132

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75904-3343PRIMAGUARD DAILY CARE SKIN PROTECTANT (LANOLIN) OINTMENT [FIRST CHOICE MEDICAL SUPPLY]2Legacy NDC, 2 package rows20130322_1ce5b0a9-092d-4ab7-b7b7-3104ba0b27d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012522lanolin 30 % Topical OintmentPSN1ce5b0a9-092d-4ab7-b7b7-3104ba0b27d22
1012522lanolin 0.3 MG/MG Topical OintmentSCD1ce5b0a9-092d-4ab7-b7b7-3104ba0b27d22
1012522lanolin 30 % Topical OintmentSY1ce5b0a9-092d-4ab7-b7b7-3104ba0b27d22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
75904-3343-4759043343045 g in 1 POUCH5 gHistorical
75904-3343-575904334305113 g in 1 TUBE113 gHistorical