FDA.reportPublic FDA data

Aquaphor Healing

Product NDC
10356-101
Requested package NDC
10356-101-06
11-digit product format
103560101
Labeler code
10356
Product ID
10356-101_460350b1-7ff7-de4e-e063-6294a90aaae4
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Beiersdorf Inc
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1991-01-01
Substance
PETROLATUM
Active strength
41 g/100g
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
Aquaphor Healing
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM41 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
725145Internal RxNorm lookup
1052954Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a17bf6f-6114-4647-a509-65999255c37bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-101-02Aquaphor Healing7 g in 1 TUBEOINTMENT720
10356-101-04Aquaphor Healing28 g in 1 TUBEOINTMENT2820
10356-101-06Aquaphor Healing50 g in 1 TUBEOINTMENT5020
10356-101-08Aquaphor Healing85 g in 1 TUBEOINTMENT8520
10356-101-10Aquaphor Healing99 g in 1 JAROINTMENT9920
10356-101-23Aquaphor Healing10 g in 1 TUBEOINTMENT1020
10356-101-29Aquaphor Healing4 g in 1 TUBEOINTMENT420
10356-101-30Aquaphor Healing0.9 g in 1 PACKETOINTMENT0.920
10356-101-35Aquaphor Healing141 g in 1 TUBEOINTMENT14120
10356-101-37Aquaphor Healing396 g in 1 JAROINTMENT39620
10356-101-38Aquaphor Healing198 g in 1 TUBEOINTMENT19820
10356-101-39Aquaphor Healing7 g in 1 JAROINTMENT720
10356-101-40Aquaphor Healing2 in 1 CARTONOINTMENT220
10356-101-42Aquaphor Healing1.7 g in 1 PACKETOINTMENT1.720
10356-101-43Aquaphor Healing250 in 1 CARTONOINTMENT25020
10356-101-44Aquaphor Healing144 in 1 CARTONOINTMENT14420
10356-101-49Aquaphor Healing297 g in 1 JAROINTMENT29720
10356-101-50Aquaphor Healing43 g in 1 TUBEOINTMENT4320
10356-101-57Aquaphor Healing80 g in 1 JAROINTMENT8020

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9UAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
PetrolatumACTIVE MOIETY4T6H12BN9UAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
CERESININACTIVE INGREDIENTQ1LS2UJO3AAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5
PANTHENOLINACTIVE INGREDIENTWV9CM0O67ZAQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10356-101AQUAPHOR HEALING (PETROLATUM) OINTMENT [BEIERSDORF INC]19Current NDC, Legacy NDC, 19 package rows20250101_0a17bf6f-6114-4647-a509-65999255c37b.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 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1052954Aquaphor 41 % Topical OintmentPSN0a17bf6f-6114-4647-a509-65999255c37b20
725145petrolatum 41 % Topical OintmentPSN0a17bf6f-6114-4647-a509-65999255c37b20
1052954petrolatum 0.41 MG/MG Topical Ointment [Aquaphor]SBD0a17bf6f-6114-4647-a509-65999255c37b20
725145petrolatum 0.41 MG/MG Topical OintmentSCD0a17bf6f-6114-4647-a509-65999255c37b20
1052954Aquaphor 0.41 MG/MG Topical OintmentSY0a17bf6f-6114-4647-a509-65999255c37b20
1052954Aquaphor 41 % Topical OintmentSY0a17bf6f-6114-4647-a509-65999255c37b20
725145petrolatum 41 % Topical OintmentSY0a17bf6f-6114-4647-a509-65999255c37b20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10356-101-061035601010650 g in 1 TUBE (10356-101-06) 50 g1991-01-010000-00-00NoNoCurrent