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 107 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief roll-on	LIDOCAINE 4%	Bionpharma Inc.	f607b6dc-8d13-604a-e053-2995a90a59ab	2024-12-23	Warnings	Exact identifier application number: M017
Veneno de Abeja Aceite De Vibora Brand	METHYL SALICYLATE	Miramar Cosmetics, Inc DBA Miramar Lab	a6c4889c-e7a9-44b9-bd9a-70fd6e8c4825	2024-12-23	Warnings	Exact identifier application number: M017
Itch Relief	HYDROCORTISONE 1%	Trifecta Pharmaceuticals USA LLC	af5daf6c-bcad-8ebf-e053-2a95a90af1b0	2024-12-20	Warnings	Exact identifier application number: M017
Pain Itch Relief	LIDOCAINE HCI	Trifecta Pharmaceutical USA LLC	f40b19a8-795c-f514-e053-2a95a90a6d15	2024-12-20	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone Cream with Aloe	HYDROCORTISONE	Rugby Laboratories	132982ea-cce6-687c-e063-6294a90a4632	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	9bb98452-a605-5c20-e053-2995a90a1ea7	2024-12-20	Warnings	Exact identifier application number: M017
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Exact identifier application number: M017
Itch Relief Cream	ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%	Pharmacy Value Alliance LLC	37fe6d82-adee-4f58-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Warrior First Aid Anti Itch	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	ec6e9a5b-c61d-a385-e053-2995a90ac936	2024-12-20	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE HCL	Derma Care Research Labs, LLC	ff227154-cf3b-9796-e053-6294a90a5535	2024-12-20	Warnings	Exact identifier application number: M017
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE HCL 4%	Meijer	f31b11ed-2ff9-5cfc-e053-2a95a90af2ca	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier application number: M017
Mirakel Pain and Itch Relief	BENZOCAINE 20%, RESORCINOL 3%	Sanvio, Inc.	ed34d728-0275-e209-e053-2995a90a93ff	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE 4%	Meijer	bed67c31-c479-6f9b-e053-2a95a90a5516	2024-12-20	Warnings	Exact identifier application number: M017
Blue-Emu Ultra with Hemp Seed	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9	2024-12-20	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	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