Hydrophor

Product NDC: 54162-500
11-digit product format: 541620500
Labeler code: 54162
Product ID: 54162-500_83041600-dd68-4f97-b97a-3931eb2ab3c9
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Geritrex LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 42 g/100g
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54162-500		I	Inactivated by FDA	2026-10-05
excluded product	product	54162-500		I	Inactivated by FDA	2026-10-05
excluded package	package	54162-500	54162-500-01	I	Inactivated by FDA	2026-10-05
excluded package	package	54162-500	54162-500-02	I	Inactivated by FDA	2026-10-05

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-500-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-500-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-500-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-500-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-500-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-500-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-500-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-500-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-500-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-500-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-500-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-500-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-500-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-500-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-500-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-500-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-500-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-500-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-500-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-500-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-500-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-500-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-500-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-500-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-500-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-500-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-500-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-500-02	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-500-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-500-02	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54162-500-01	2020-01-31	C162847	48780-1	9d75b9d0-113e-f424-e053-dadaa90a57ce	Hydrophor Ointment
54162-500-02	2020-01-31	C162847	48780-1	9d75b9d1-0e1f-f424-e053-dadaa90a57ce	Hydrophor Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-500-01	Hydrophor	454 g in 1 JAR	OINTMENT	454		5
54162-500-02	Hydrophor	100 g in 1 JAR	OINTMENT	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-500-01	GM - Gram	54162-500	8fbba6cf-ee7d-4308-b22d-d21dcf6c2a48	1	2012-07-24
54162-500-02	GM - Gram	54162-500	9e6a2773-884b-4094-9f8f-5ed4de39d971	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	2
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
CERESIN	INACTIVE INGREDIENT	Q1LS2UJO3A	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
LANOLIN ALCOHOLS	INACTIVE INGREDIENT	884C3FA9HE	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-500	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX LLC]	5	Legacy NDC, 1 package rows	20180119_00d30389-5f92-45fa-90cc-c263451f45a6.zip
54162-500	HYDROPHOR (PETROLATUM) OINTMENT [GERITREX LLC]	2	Legacy NDC, 1 package rows	20160318_79270fe6-115f-4830-82db-1dc1872cba9d.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
835547	petrolatum 42 % Topical Ointment	PSN	00d30389-5f92-45fa-90cc-c263451f45a6	5
835547	petrolatum 0.42 MG/MG Topical Ointment	SCD	00d30389-5f92-45fa-90cc-c263451f45a6	5
835547	petrolatum 42 % Topical Ointment	SY	00d30389-5f92-45fa-90cc-c263451f45a6	5
835547	petrolatum 42 % Topical Ointment	PSN	79270fe6-115f-4830-82db-1dc1872cba9d	2
835547	petrolatum 0.42 MG/MG Topical Ointment	SCD	79270fe6-115f-4830-82db-1dc1872cba9d	2
835547	petrolatum 42 % Topical Ointment	SY	79270fe6-115f-4830-82db-1dc1872cba9d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-500-01	54162050001	454 g in 1 JAR	454 g	Historical
54162-500-02	54162050002	100 g in 1 JAR	100 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hydrophor Ointment	Geritrex LLC	2018-01-17	HUMAN OTC DRUG LABEL	5
Hydrophor Ointment	Geritrex LLC	2016-01-08	HUMAN OTC DRUG LABEL	2