Quality Choice Quick Relief Diaper Rash

Product NDC: 63868-164
11-digit product format: 638680164
Labeler code: 63868
Product ID: 63868-164_edf9e143-c2cc-4877-a7b3-cda18aa6a7b9
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Chain Drug Marketing Association
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-04-01
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 13 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-164		I	Inactivated by FDA		2026-10-05
excluded package	package	63868-164	63868-164-04	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 1 · 42 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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`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	63868-164-04	`9bebd1f3094a…`	`5416666fcb17…`

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
63868-164-04	2020-01-31	C162847	48780-1	9d75b9d0-7be8-f424-e053-dadaa90a57ce	Quick Relief Diaper Rash Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-164-04	Quality Choice Quick Relief Diaper Rash	1 in 1 CARTON	CREAM	1		1
63868-164-04	Quality Choice Quick Relief Diaper Rash	113 g in 1 TUBE	CREAM	113		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
MICROCRYSTALLINE WAX	INACTIVE INGREDIENT	XOF597Q3KY	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
PEG-30 DIPOLYHYDROXYSTEARATE	INACTIVE INGREDIENT	9713Q0S7FO	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
POLYGLYCERYL-3 DIISOSTEARATE	INACTIVE INGREDIENT	46P231IQV8	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
ROYAL JELLY	INACTIVE INGREDIENT	L497I37F0C	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-164	QUALITY CHOICE QUICK RELIEF DIAPER RASH (ZINC OXIDE) CREAM [CHAIN DRUG MARKETING ASSOCIATION]	1	Legacy NDC, 2 package rows	20140410_edf9e143-c2cc-4877-a7b3-cda18aa6a7b9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349404	zinc oxide 13 % Topical Cream	PSN	edf9e143-c2cc-4877-a7b3-cda18aa6a7b9	1
349404	zinc oxide 130 MG/ML Topical Cream	SCD	edf9e143-c2cc-4877-a7b3-cda18aa6a7b9	1
349404	zinc oxide 13 % Topical Cream	SY	edf9e143-c2cc-4877-a7b3-cda18aa6a7b9	1
349404	ZNO 130 MG/ML Topical Cream	SY	edf9e143-c2cc-4877-a7b3-cda18aa6a7b9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
63868-164-04	63868016404	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quick Relief Diaper Rash Cream	Chain Drug Marketing Association	2014-04-08	HUMAN OTC DRUG LABEL	1