Petroleum Jelly

Product NDC
13709-331
11-digit product format
137090331
Labeler code
13709
Product ID
13709-331_3a73aa52-55b0-9912-e063-6394a90a8793
Type
HUMAN OTC DRUG
Nonproprietary name
Petroleum Jelly
Dosage form
JELLY
Route
TOPICAL
Labeler
NeilMed Pharmaceuticals Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-04
Substance
WHITE PETROLATUM
Active strength
100 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
Petroleum Jelly
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WHITE PETROLATUM100 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B6E5W8RQJ4Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
36bbbb1e-78e9-98f6-e063-6294a90a66d1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-331-01Petroleum Jelly50 g in 1 JARJELLY502
13709-331-02Petroleum Jelly368 g in 1 JARJELLY3682

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 53 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
application number: M016
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
application number: M016
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
application number: M016
VITAMIN A and DVITAMIN A AND DALLIED TRADE LINK LLC26d426c3-4dfb-c984-e063-6394a90a37932024-11-13WarningsExact identifier
application number: M016
ZO Skin Health Post Procedure ProgramALUMINUM ACETATEZO Skin Health, Inc.9786acc8-06ae-4f2b-9602-b7e8c3baeca52024-11-12WarningsExact identifier
application number: M016
DUKAL WHITE PETROLATUMPETROLATUMDukal LLC0c6474ed-2343-d5f2-e063-6394a90a30b32024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Health2fead2d8-b645-4d45-8e5b-b4f1da4e5a252024-11-12WarningsExact identifier
application number: M016
CVS Health Advanced Scar GelADVANCED SCAR GELCVS Healthc6926594-ad4e-4937-bda2-9311219a88812024-11-12WarningsExact identifier
application number: M016
CVS Zinc OxideZINC OXIDECVS Healthd67533b1-ae3f-4c9a-a6c9-a742290c90e92024-11-11WarningsExact identifier
application number: M016
CVS Eczema Relief Skin ProtectantOATMEALCVS Health3cf25c43-592f-41cb-aa0b-a82f4e7faf3d2024-11-11WarningsExact identifier
application number: M016
DGH Advanced Formula Scar Skin ProtectantALLANTOINDolgencorp Inc950dcffd-d2c3-4ca7-8a15-7cb1016ca3642024-11-08WarningsExact identifier
application number: M016
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
application number: M016
SUPER SENSITIVE DIAPER RASHZINC OXIDEORGANIC & SUSTAINABLE BEAUTYb0de2a9b-7854-4caf-b7ff-632c1d4a382e2024-11-08WarningsExact identifier
application number: M016
DoveDERMASERIES ECZEMA RELIEF SOOTHING BODY LOTIONConopco, Inc. d/b/a/ Unileverbcfb12ea-304e-7d8c-e053-2a95a90af6062024-11-07WarningsExact identifier
application number: M016
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
application number: M016
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
application number: M016
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN36bbbb1e-78e9-98f6-e063-6294a90a66d12
204754petrolatum 1 MG/MG Topical OintmentSCD36bbbb1e-78e9-98f6-e063-6294a90a66d12
204754petrolatum 100 % Topical JellySY36bbbb1e-78e9-98f6-e063-6294a90a66d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-331-011370903310150 g in 1 JAR (13709-331-01) 50 g2025-06-04NoNoCurrent
13709-331-0213709033102368 g in 1 JAR (13709-331-02) 368 g2025-06-04NoNoCurrent