FDA.reportPublic FDA data

A and D

Product NDC
67234-030
Requested package NDC
67234-030-01
11-digit product format
672340030
Labeler code
67234
Product ID
67234-030_79f50a4e-0536-4ac9-b58b-81b22fdb5b99
Type
HUMAN OTC DRUG
Nonproprietary name
Lanolin and Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-11-12
Substance
LANOLIN; PETROLATUM
Active strength
.15; .53 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
A and D
Brand name suffix
Diaper Rash and Skin Protectant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LANOLIN.15 mg/g
PETROLATUM.53 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
664981Internal RxNorm lookup
705895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcaf27c9-3634-4fb7-a311-2e093f055278Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-030-01A and D Diaper Rash and Skin Protectant42.5 g in 1 TUBECREAM42.54
67234-030-01A and D Diaper Rash and Skin Protectant1 in 1 BOXCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LanolinACTIVE INGREDIENT7EV65EAW6HA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
PetrolatumACTIVE INGREDIENT4T6H12BN9UA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
LanolinACTIVE MOIETY7EV65EAW6HA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
PetrolatumACTIVE MOIETY4T6H12BN9UA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
COD LIVER OILINACTIVE INGREDIENTBBL281NWFGA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VA AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-030A AND D DIAPER RASH AND SKIN PROTECTANT (LANOLIN AND PETROLATUM) CREAM [NATUREPLEX LLC]4Current NDC, Legacy NDC, 2 package rows20250109_fcaf27c9-3634-4fb7-a311-2e093f055278.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 64 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016
GNP Witch HazelWITCH HAZELAmerisource Bergen45ac839d-215d-4c5f-8ae5-5e111d1700612023-12-14WarningsExact identifier
application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Defense B5 Skin ProtectantGLYCERINL'Oreal USA Products Inc32eaaaab-41bd-4efe-a71d-92e3a702c1e52023-12-11WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705895A+D Original 15.5 % / 53.4 % Topical OintmentPSNfcaf27c9-3634-4fb7-a311-2e093f0552784
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentPSNfcaf27c9-3634-4fb7-a311-2e093f0552784
705895lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical Ointment [A+D Original]SBDfcaf27c9-3634-4fb7-a311-2e093f0552784
664981lanolin 0.155 MG/MG / petrolatum 0.534 MG/MG Topical OintmentSCDfcaf27c9-3634-4fb7-a311-2e093f0552784
705895A+D Original (lanolin 15.5 % / petrolatum 53.4 % ) Topical OintmentSYfcaf27c9-3634-4fb7-a311-2e093f0552784
664981lanolin 15.5 % / petrolatum 53.4 % Topical OintmentSYfcaf27c9-3634-4fb7-a311-2e093f0552784
664981lanolin 15.5 GM per 100 GM / petrolatum 53.4 GM per 100 GM Topical OintmentSYfcaf27c9-3634-4fb7-a311-2e093f0552784

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-030-01672340030011 TUBE in 1 BOX (67234-030-01) / 42.5 g in 1 TUBE1 tube2014-11-120000-00-00NoNoCurrent