PREMIER VALUE ALLERGY

Product NDC: 68169-0127
11-digit product format: 681690127
Labeler code: 68169
Product ID: 68169-0127_8f6ba017-40c2-4a36-999a-886a1df70cca
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: CREAM
Route: TOPICAL
Labeler: TAI GUK PHARM. CO., LTD.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2010-09-17
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 2 g/100g; g/100g
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	68169-0127		I	Inactivated by FDA		2026-10-12
excluded package	package	68169-0127	68169-0127-6	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 · 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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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	68169-0127-6	`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
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68169-0127-6	2019-10-21	C162847	48780-1	956f9ecf-ce61-621f-e053-dbdaa90a74ad	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68169-0127-6	PREMIER VALUE ALLERGY	28 g in 1 TUBE	CREAM	28		4
68169-0127-6	PREMIER VALUE ALLERGY	1 in 1 CARTON	CREAM	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
ZINC	ACTIVE MOIETY	J41CSQ7QDS	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
DISTEARYLDIMONIUM CHLORIDE	INACTIVE INGREDIENT	OM9573ZX3X	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
ISOPROPYL PALMITATE	INACTIVE INGREDIENT	8CRQ2TH63M	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68169-0127	PREMIER VALUE ALLERGY (DIPHENHYDRAMINE HYDROCHLORIDE) CREAM [TAI GUK PHARM. CO., LTD.]	4	Legacy NDC, 2 package rows	20100923_3fd4a047-6da6-4b1d-8138-a8dbbc1d00ea.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
FM5526K07A	ZINC ACETATE	5970-45-6	ZINC ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1087026	diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream	PSN	3fd4a047-6da6-4b1d-8138-a8dbbc1d00ea	4
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	3fd4a047-6da6-4b1d-8138-a8dbbc1d00ea	4
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	3fd4a047-6da6-4b1d-8138-a8dbbc1d00ea	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68169-0127-6	68169012706	28 g in 1 TUBE	28 g	Historical