Petrolatum Jelly

Product NDC: 77338-162
11-digit product format: 773380162
Labeler code: 77338
Product ID: 77338-162_16dac8e5-aeb9-592d-e063-6394a90ae2b6
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: JELLY
Route: TOPICAL
Labeler: ASTONEA LABS PRIVATE LIMITED
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-11
Substance: PETROLATUM
Active strength: 99.6 g/100g
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: Petrolatum Jelly
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PETROLATUM	99.6 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1252009	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
16dac8e5-aeb8-592d-e063-6394a90ae2b6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
77338-162-01	Petrolatum Jelly	100 g in 1 JAR	JELLY	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77338-162	PETROLATUM JELLY (PETROLATUM) JELLY [ASTONEA LABS PRIVATE LIMITED]	1	Current NDC, 1 package rows	20240426_16dac8e5-aeb8-592d-e063-6394a90ae2b6.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 20 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diaper Rash	ZINC OXIDE	Target Corporation	8059f489-f144-4de5-9454-ac6c1af35dd2	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Coconut Milk and Shea Petroleum Jelly	WHITE PETROLATUM	Target Corporation	c78d9864-92e0-4ad8-8a9b-9752ac6784e8	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	043375b2-e636-4822-9e05-df2327d29986	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Strategic Sourcing Services LLC	3ade1f7f-a870-4f77-96b9-f63bf4cdf5ae	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Valu Merchandisers Company	4113bb6e-070a-4116-a8d6-12c6b4475beb	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Valu Merchandisers Company	e5465ddd-e38c-44a4-bb9b-3edbc636576d	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Valu Merchandisers Company	8b8decec-e921-4ff9-bb49-7e38e34724f6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Valu Merchandisers Company	0cccadd7-11f3-5d1f-e063-6294a90a55c4	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Valu Merchandisers Company	7c6fa37f-79b8-4409-b7a9-3f02332f887a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	014d0028-486e-4f1c-a14f-8162e393ebca	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	United Natural Foods, Inc. dba UNFI	29a3a719-5e8b-407d-b9d9-bdba26758292	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Topco Associates LLC	8acb1b47-70ed-4aa2-a7c0-e807042affc7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Topco Associates LLC	3babe2cf-9e6c-4f22-940f-c1fdf489f1c7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Topco Associates LLC	8d3d1ff5-4868-495d-807c-e45aa2176f63	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Topco Associates LLC	b929b159-4af5-4a03-8e7c-676a6ba2bf55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Topco Associates LLC	cd7f1727-0b6e-4993-9820-43783994efa1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Topco Associates LLC	f37f17f7-f084-4b74-8361-178d2315a476	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Topco Associates LLC	4f6af42c-f41e-455f-b94b-3793bf0b9a3f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1252009	petrolatum 99.6 % Topical Gel	PSN	16dac8e5-aeb8-592d-e063-6394a90ae2b6	1
1252009	petrolatum 0.996 MG/MG Topical Gel	SCD	16dac8e5-aeb8-592d-e063-6394a90ae2b6	1
1252009	white petrolatum 99.6 % Topical Gel	SY	16dac8e5-aeb8-592d-e063-6394a90ae2b6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
77338-162-01	77338016201	100 g in 1 JAR (77338-162-01)	100 g	2023-01-01	No	No	Current