FDA.reportPublic FDA data

Vitamin A D

Product NDC
36800-017
11-digit product format
368000017
Labeler code
36800
Product ID
36800-017_4df1208d-8731-51da-e063-6294a90a2ae2
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin, Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Topco Associates LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-01-27
Substance
LANOLIN; PETROLATUM
Active strength
155; 534 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Vitamin A D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN155 mg/g
PETROLATUM534 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7EV65EAW6HInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664981Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5126fdf6-5df5-474b-bc0d-3a82dea61abbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-017-26Vitamin A D113 g in 1 TUBEOINTMENT11317
36800-017-26Vitamin A D1 in 1 CARTONOINTMENT117

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LANOLINACTIVE INGREDIENT7EV65EAW6HVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
PETROLATUMACTIVE INGREDIENT4T6H12BN9UVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
LANOLINACTIVE MOIETY7EV65EAW6HVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
PETROLATUMACTIVE MOIETY4T6H12BN9UVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZEVITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-017VITAMIN A D (LANOLIN, PETROLATUM) OINTMENT [TOPCO ASSOCIATES LLC]14Current NDC, Legacy NDC, 2 package rows20240404_5126fdf6-5df5-474b-bc0d-3a82dea61abb.zip

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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSN5126fdf6-5df5-474b-bc0d-3a82dea61abb17
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCD5126fdf6-5df5-474b-bc0d-3a82dea61abb17
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSY5126fdf6-5df5-474b-bc0d-3a82dea61abb17
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSY5126fdf6-5df5-474b-bc0d-3a82dea61abb17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-017-26368000017261 TUBE in 1 CARTON (36800-017-26) / 113 g in 1 TUBE1 tube2014-07-270000-00-00NoNoCurrent