diphenhydramine hcl and zinc acetate

Product NDC: 45802-358
11-digit product format: 458020358
Labeler code: 45802
Product ID: 45802-358_888ad1f9-aeb1-4778-8d5a-734e734036e6
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form: CREAM
Route: TOPICAL
Labeler: Padagis Israel Pharmaceuticals Ltd
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2005-12-05
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength: 2; .1 g/100g; g/100g
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: diphenhydramine hcl and zinc acetate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	2 g/100g
ZINC ACETATE	.1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
FM5526K07A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1087026	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6d7a7615-9ae7-4c55-8a84-dba746f535d7	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-358-03	diphenhydramine hcl and zinc acetate	1 in 1 CARTON	CREAM	1		7
45802-358-03	diphenhydramine hcl and zinc acetate	28 g in 1 TUBE	CREAM	28		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-358-03	GM - Gram	45802-358	5ee96519-a817-4023-a42d-f209f5a5fe72	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
ZINC ACETATE	ACTIVE INGREDIENT	FM5526K07A	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
ZINC	ACTIVE MOIETY	J41CSQ7QDS	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
DIAZOLIDINYL UREA	INACTIVE INGREDIENT	H5RIZ3MPW4	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
PEG-2 STEARATE	INACTIVE INGREDIENT	94YQ11Y95F	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
PEG-20 STEARATE	INACTIVE INGREDIENT	NBX892EA57	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-358	DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]	6	Current NDC, Legacy NDC, 2 package rows	20240830_6d7a7615-9ae7-4c55-8a84-dba746f535d7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 94 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Stop Itch Gel	DIPHENHYDRAMINE HCL	Walgreens Co	23586336-8f46-3dcd-e063-6394a90accc9	2025-05-04	Warnings	Exact identifier application number: M017
WaxRx EarAcheRx Pain Relieving Drops	4% LIDOCAINE HCL	DOCTOR EASY MEDICAL PRODUCTS, LLC	34156655-8706-f0a4-e063-6294a90acc90	2025-05-01	Warnings	Exact identifier application number: M017
foster and thrive anti itch cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Strategic Sourcing Services LLC	bb08293d-5db8-4cc8-9fe3-bd02061dbeb9	2025-04-30	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	Solis Pharmaceuticals Inc.	3061d301-2104-b1b2-e063-6394a90a9b6e	2025-04-29	Warnings	Exact identifier application number: M017
Maximum Strength 4% Lidocaine Patch	LIDOCAINE	InterMed Laboratories Private Limited	33ed754e-8852-d5b2-e063-6394a90a7cf2	2025-04-29	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	InterMed Laboratories Private Limited	33ee6e48-243e-4ded-e063-6394a90a987d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	32b96689-8e9b-4c2e-e063-6294a90a7d1c	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3304e362-dcda-3f5e-e063-6294a90a7015	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	2f2f753d-c791-e863-e063-6394a90aec5d	2025-04-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel-Patch	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	3162c96a-061d-2971-e063-6394a90a9b74	2025-04-29	Warnings	Exact identifier application number: M017
Ivarest Poison Ivy Removal and Itch Relief	PRAMOXINE HYDROCHLORIDE	Blistex Inc.	dedbf5d9-0f86-4f32-8321-da86c9838c0a	2025-04-29	Warnings	Exact identifier application number: M017
HealthWise 2X Medicated Pain Relief Cream Roll-on	MENTHOL	Veridian Healthcare	33dae8a8-4197-f276-e063-6294a90aea83	2025-04-28	Warnings	Exact identifier application number: M017
HealthWise Roll-on Menthol Pain Relief Gel	MENTHOL	Veridian Healthcare	33dbb939-9397-7e70-e063-6294a90ac8f4	2025-04-28	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	fa1a98bc-c233-410d-a20e-71111c897372	2025-04-28	Warnings	Exact identifier application number: M017
Lidocaine Patch 4%	LIDOCAINE 4%	Medcore LLC	b961906c-fe66-466b-af2c-072781fa098b	2025-04-28	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Knee and Elbow	LIDOCAINE	Walgreen Co.	a3fb4c78-1493-4ba4-ae83-502dd825ed67	2025-04-25	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Back	LIDOCAINE	Walgreen Co.	e6bfd342-c0db-46b9-b5e6-5acbd860adf1	2025-04-25	Warnings	Exact identifier application number: M017
Electrum Numb Foam	LIDOCAINE HCI	RENU LABORATORIES, LLC	c8472932-28b7-9189-e053-2a95a90a44df	2025-04-25	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	66a2fd60-1757-45cc-a195-ecb9241dca2a	2025-04-24	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Zanming Trading Co., Ltd.	3385cddb-609f-62e8-e063-6294a90add81	2025-04-24	Warnings	Exact identifier application number: M017

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	6d7a7615-9ae7-4c55-8a84-dba746f535d7	7
1087026	diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream	SCD	6d7a7615-9ae7-4c55-8a84-dba746f535d7	7
1087026	diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream	SY	6d7a7615-9ae7-4c55-8a84-dba746f535d7	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45802-358-03	45802035803	1 TUBE in 1 CARTON (45802-358-03) / 28 g in 1 TUBE	1 tube	2005-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diphenhydramine HCl & Zinc Acetate Drug Facts	Padagis Israel Pharmaceuticals Ltd	2026-01-14	HUMAN OTC DRUG LABEL	7
Perrigo Diphenhydramine HCl & Zinc Acetate Drug Facts	A-S Medication Solutions	2023-05-09	HUMAN OTC DRUG LABEL	2