Anti-Itch Cream

Product NDC: 63868-683
Requested package NDC: 63868-683-01
11-digit product format: 638680683
Labeler code: 63868
Product ID: 63868-683_bafdf06b-25f3-e29e-e053-2a95a90a5e1b
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine hydrochloride 2%, zinc acetate 0.1%
Dosage form: CREAM
Route: TOPICAL
Labeler: Chain Drug Marketing Association Inc.
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-08-14
Marketing end: 0000-00-00
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 2 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
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	63868-683	63868-683-01	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 · 9 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	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
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
63868-683-01	2025-01-30	C162847	48780-1	f386c64a-422c-0266-e053-dadaa90a7c1a	Quality Choice Extra Strength Anti-Itch Cream
63868-683-01	2023-05-25	C162847	48780-1	f386c64a-422c-0266-e053-dadaa90a7c1a	Quality Choice Extra Strength Anti-Itch Cream
63868-683-01	2023-01-30	C162847	48780-1	f386c64a-422c-0266-e053-dadaa90a7c1a	Quality Choice Extra Strength Anti-Itch Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-683-01	Anti-Itch Cream	1 in 1 BOX	CREAM	1		3
63868-683-01	Anti-Itch Cream	28.3 g in 1 TUBE	CREAM	28.3		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-683-01	GM - Gram	63868-683	c1ec8355-2f46-4b25-a50f-5d294c613bcf	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-683	ANTI-ITCH CREAM (DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC.]	3	Legacy NDC, 2 package rows	20230526_acdd7406-9dc3-235f-e053-2a95a90a2df7.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	acdd7406-9dc3-235f-e053-2a95a90a2df7	3
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	acdd7406-9dc3-235f-e053-2a95a90a2df7	3
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	acdd7406-9dc3-235f-e053-2a95a90a2df7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-683-01	63868068301	1 TUBE in 1 BOX (63868-683-01) > 28.3 g in 1 TUBE	1 tube	2020-08-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Extra Strength Anti-Itch Cream	Chain Drug Marketing Association Inc. \| Trifecta Pharmaceuticals USA LLC.	2023-05-25	HUMAN OTC DRUG LABEL	3