FDA.reportPublic FDA data

Aquaphor Original Ointment

Manufacturer
Beiersdorf Inc
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:25:29

Label at a glance#

ProductAquaphor Original
Active ingredientPETROLATUM
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 41%

OTC - PURPOSE SECTION

Purpose

Skin Protectant Ointment

INDICATIONS & USAGE SECTION

Uses

• temporarily protects minor: • cuts • scrapes • burns
• temporarily protects and helps relieve chapped or cracked skin and lips
• helps protect from the drying effects of wind and cold weather

WARNINGS SECTION

Warnings

For external use only

When using this product • do not get into eyes

OTC - DO NOT USE SECTION

Do not use on

• deep or puncture wounds • animal bites
• serious burns

OTC - STOP USE SECTION

Stop use and ask a doctor if • condition worsens
• symptoms last more than 7 days or clear up and occur
again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help
or contact a Poison Control Center right away.

INACTIVE INGREDIENT SECTION

Mineral Oil, Ceresin, Lanolin Alcohol

OTC - QUESTIONS SECTION

Questions or comments?
1-800-227-4703

DOSAGE & ADMINISTRATION SECTION

Directions

Apply as needed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

aoofrontaoofront

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Aquaphor Original Ointment

Severly Dry Skin Treatment

Clinically proven to restore smooth, healthy skin

Preservative and Fragrance Free

Skin Protectant

Dermatologist recommended

For the pharmacist: Aquaphor provides an ideal base for compounding smooth, stable emulsions.

It is highly miscible with aqueous solutions as well as oil-based substances.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1052954Aquaphor 41 % Topical OintmentPSN16
725145petrolatum 41 % Topical OintmentPSN16
1052954petrolatum 0.41 MG/MG Topical Ointment [Aquaphor]SBD16
725145petrolatum 0.41 MG/MG Topical OintmentSCD16
1052954Aquaphor 0.41 MG/MG Topical OintmentSY16
1052954Aquaphor 41 % Topical OintmentSY16
725145petrolatum 41 % Topical OintmentSY16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10356-100-37Aquaphor Original396 g in 1 JAROINTMENT39616

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PetrolatumACTIVE INGREDIENT4T6H12BN9U2
PetrolatumACTIVE MOIETY4T6H12BN9U2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10356-10010356-100-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
CERESINQ1LS2UJO3AIACT
LANOLIN ALCOHOLS884C3FA9HEIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aquaphor OriginalPETROLATUMBeiersdorf Incd38ec874-7b8c-4b9b-92b6-286278bb67f32025-12-15WarningsExact identifier
ndc (package): 10356-100-37
ndc (product): 10356-100
ndc11 (package): 10356010037
spl id: 46041c57-79d9-e56c-e063-6394a90a8783
spl set id: d38ec874-7b8c-4b9b-92b6-286278bb67f3

Reported adverse events (FAERS/openFDA)#

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