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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
application number: M016
White PetrolatumWHITE PETROLATUMSled Distribution, LLCe73a4b7a-7b27-abfc-e053-2995a90a35c22024-01-15WarningsExact identifier
application number: M016
Sunmark CaldiphenCALAMINE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services4f4d4c54-64b5-4e20-bed0-c7fb470b84342024-01-12WarningsExact identifier
application number: M016
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Eczema Relief CreamyOATMEALL'Oreal USA Products Incbcf7b985-6875-4033-a412-1bb6d3afa6d82024-01-01WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists HealingPETROLATUML'Oreal USA Products Inc.1b3ad3e8-cbac-4a92-84e2-4f3ab4512d952023-12-31WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Baby HealingPETROLATUML'Oreal USA Products Inc.fe665bbc-1172-4f59-acc6-8d5c179693b62023-12-31WarningsExact identifier
application number: M016
Quality Choice Anti-Itch ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEChain Drug Market Associatione3c0c46d-3d85-411d-a543-009064cdd19e2023-12-28WarningsExact identifier
application number: M016
CeraVe Developed with Dermatologists Therapeutic HandDIMETHICONEL'Oreal USA Products Inc7fe49112-4180-415c-a380-768a8d6b21852023-12-28WarningsExact identifier
application number: M016
CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEPharma Nobis, LLCe42fccc2-1b4e-e7f3-e053-2a95a90aef392023-12-26WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLPharma Nobis, LLCe42fbdcc-3291-7761-e053-2995a90a71722023-12-26WarningsExact identifier
application number: M016
Humco CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDEPharma Nobis, LLCe42fb807-8cb4-ed25-e053-2995a90a67802023-12-26WarningsExact identifier
application number: M016
Leader Calamine PlusZINC OXIDE LOTIONCardinal Health, 110 dba Leader81f29789-f794-1e64-e053-2a91aa0ac85e2023-12-22WarningsExact identifier
application number: M016
CVS Calamine PlusZINC OXIDECVS Pharmacyb90cd214-d44a-4458-876d-59cc0795226d2023-12-22WarningsExact identifier
application number: M016
CalamineCALAMINE 8% AND ZINC OXIDE 8%Pharma Nobis, LLCe42f0bd6-3ad3-7e07-e053-2995a90a564a2023-12-22WarningsExact identifier
application number: M016
DDM CalamineCALAMINE 8% AND ZINC OXIDE 8%Discount Drug Mart5d53685b-ca4c-35c1-e053-2a91aa0aff6e2023-12-20WarningsExact identifier
application number: M016
DDM CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d537a11-049e-0a8d-e053-2a91aa0aa0c32023-12-20WarningsExact identifier
application number: M016
Health Mart CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLC349ea07d-79bc-46f3-9d60-85b40db51bbb2023-12-20WarningsExact identifier
application number: M016
Health Mart Witch HazelWITCH HAZELStrategic Sourcing Services LLC2a1d9b27-0bd4-4475-8218-ba0f5560a9692023-12-20WarningsExact identifier
application number: M016
Quality Choice CalamineCALAMINE 8% AND ZINC OXIDE 8%Chain Drug Market Association62fe653f-e861-472b-b193-4fdd9d25de8d2023-12-20WarningsExact 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