PETROLEUM

Product NDC: 63517-211
Requested package NDC: 63517-211-05
11-digit product format: 635170211
Labeler code: 63517
Product ID: 63517-211_efa7d0a1-51e5-ec2d-e053-2995a90a840d
Type: HUMAN OTC DRUG
Nonproprietary name: PETROLATUM
Dosage form: JELLY
Route: TOPICAL
Labeler: Cardinal Health
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-08-26
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 1 g/g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63517-211	63517-211-05	I	Inactivated by FDA		2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63517-211-01	2024-01-30	Petrolatum Jelly
63517-211-03	2024-01-30	Petrolatum Jelly
63517-211-05	2024-01-30	Petrolatum Jelly
63517-211-10	2024-01-30	Petrolatum Jelly
63517-211-01	2022-01-21	Petrolatum Jelly
63517-211-03	2022-01-21	Petrolatum Jelly
63517-211-05	2022-01-21	Petrolatum Jelly
63517-211-10	2022-01-21	Petrolatum Jelly
63517-211-01	2020-01-31	Petrolatum Jelly
63517-211-03	2020-01-31	Petrolatum Jelly
63517-211-05	2020-01-31	Petrolatum Jelly
63517-211-10	2020-01-31	Petrolatum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63517-211-01	PETROLEUM	6 in 1 CASE	JELLY	6	3
63517-211-01	PETROLEUM	144 in 1 BOX	JELLY	144	3
63517-211-03	PETROLEUM	100 in 1 CASE	JELLY	100	3
63517-211-03	PETROLEUM	28.3 g in 1 TUBE	JELLY	28.3	3
63517-211-05	PETROLEUM	100 in 1 CASE	JELLY	100	3
63517-211-05	PETROLEUM	92.14 g in 1 TUBE	JELLY	92.14	3
63517-211-10	PETROLEUM	284 g in 1 TUBE	JELLY	284	3
63517-211-10	PETROLEUM	24 in 1 CASE	JELLY	24	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PETROLEUM (PETROLATUM) JELLY [CARDINAL HEALTH]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PETROLEUM (PETROLATUM) JELLY [CARDINAL HEALTH]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63517-211	PETROLEUM (PETROLATUM) JELLY [CARDINAL HEALTH]	3	Legacy NDC, 8 package rows	20221213_f04337fb-6245-47f2-b2e6-7974feb3f644.zip

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
204754	petrolatum 100 % Topical Jelly	PSN	f04337fb-6245-47f2-b2e6-7974feb3f644	3
204754	petrolatum 1 MG/MG Topical Ointment	SCD	f04337fb-6245-47f2-b2e6-7974feb3f644	3
204754	petrolatum 100 % Topical Jelly	SY	f04337fb-6245-47f2-b2e6-7974feb3f644	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63517-211-05	63517021105	100 TUBE in 1 CASE (63517-211-05) > 92.14 g in 1 TUBE	100 tube	2015-10-15	0000-00-00	No	No	Current