MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE

Product NDC: 59779-399
11-digit product format: 597790399
Labeler code: 59779
Product ID: 59779-399_de6ea099-3261-4190-9166-b98319cbbdc3
Type: HUMAN OTC DRUG
Nonproprietary name: MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: CVS Pharmacy
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-07-16
Marketing end: 0000-00-00
Substance: MINERAL OIL; PRAMOXINE HYDROCHLORIDE; ZINC OXIDE
Active strength: 466 mg/g; mg/g; mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	59779-399		I	Inactivated by FDA		2026-10-16
excluded package	package	59779-399	59779-399-03	I	Inactivated by FDA		2026-10-16

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 · 44 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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`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 package	package	59779-399-03	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59779-399-03	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59779-399-03	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59779-399-03	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59779-399-03	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59779-399-03	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	59779-399-03	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59779-399-03	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59779-399-03	2019-10-29	C162847	48780-1	960f7f55-d0f7-8e05-e053-dbdaa90a074a	drug facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59779-399-03	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE	28 g in 1 TUBE, WITH APPLICATOR	CREAM	28		1
59779-399-03	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE	1 in 1 CARTON	CREAM	1		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MINERAL OIL	ACTIVE INGREDIENT	T5L8T28FGP	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
PRAMOXINE HYDROCHLORIDE	ACTIVE INGREDIENT	88AYB867L5	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
MINERAL OIL	ACTIVE MOIETY	T5L8T28FGP	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
PRAMOXINE	ACTIVE MOIETY	068X84E056	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
BALSAM PERU	INACTIVE INGREDIENT	8P5F881OCY	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
BENZYL BENZOATE	INACTIVE INGREDIENT	N863NB338G	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
CALCIUM PHOSPHATE	INACTIVE INGREDIENT	97Z1WI3NDX	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
COCOA BUTTER	INACTIVE INGREDIENT	512OYT1CRR	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
GLYCERYL MONOOLEATE	INACTIVE INGREDIENT	4PC054V79P	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-399	MINERAL OIL, PRAMOXINE HYDROCHLORIDE AND ZINC OXIDE CREAM [CVS PHARMACY]	1	Legacy NDC, 2 package rows	20110721_f15b86b3-8f6a-4a6e-9df4-24718e2751d4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
T5L8T28FGP	MINERAL OIL	8042-47-5	MINERAL OIL
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
59779-399-03	59779039903	28 g in 1 TUBE, WITH APPLICATOR	28 g	Historical