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 146 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPER BLUE STUFF Pain Relief Cream	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	066a2106-2e25-4df6-9a8d-4417ba190205	2023-11-10	Warnings	Exact identifier application number: M017
INVIGO FLEX Pain Relief Gel	MENTHOL	WYNNPHARM INC.	909e1d8c-c517-4d6a-8682-894f042c00f8	2023-11-10	Warnings	Exact identifier application number: M017
ARNIMAX Penetrating Pain Relief Gel	MENTHOL	WYNNPHARM INC.	3a31f805-19c6-4036-a663-ebef9b212007	2023-11-10	Warnings	Exact identifier application number: M017
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Exact identifier application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVING	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	da004500-5e48-487b-b96f-520a3094096c	2023-11-10	Warnings	Exact identifier application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
NEUROFLEX Topical Pain Relieving Liquid	CAMPHOR (SYNTHETIC), MENTHOL	Almark Products Inc	6da3aa84-7a01-4041-8792-a4bbf49e6e4e	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR 60-second Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	3b74b542-202f-469e-8025-4372e95e6b01	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f8b8d1-a20b-54b0-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f92e71-fe2e-16f4-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier application number: M017
Teeter Renew Muscles Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	b90dc5b9-c31d-4770-a291-98d036ae8723	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR Foot and Leg Rub	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	57094238-506b-48c1-8eb9-fe904be80df0	2023-11-10	Warnings	Exact identifier application number: M017
SKIN A COOL Hydrocortisone Anti-Itch	HYDROCORTISONE	Ana-Cool, LLC	e3ea7406-e494-4038-9b28-8d0a28b4b834	2023-11-10	Warnings	Exact identifier application number: M017
Teeter reNEW MUSCLES Pain Relieving	METHYL SALICYLATE, MENTHOL	STL International INC	ebc777b0-d141-4a62-9366-d14787eaefe0	2023-11-10	Warnings	Exact identifier application number: M017
FEELGOOD LAB Natural Pain Cream	MENTHOL	The Feel Good Lab, LLC	799d464c-aaf1-429a-877b-2a692397bb49	2023-11-10	Warnings	Exact identifier application number: M017
HIGHER CONTROL Male Climax Control Lubricating	BENZOCAINE	Product Max Group Inc	5f5fd127-34c5-403a-aa95-c9874ae79492	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f93076-1f68-58e6-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f9622e-27c7-6a5d-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
FEEL GOOD LAB Natural Pain Cream	MENTHOL	THE FEEL GOOD LAB, LLC	774a72b1-b719-4217-846e-7f9921fd1b16	2023-11-10	Warnings	Exact identifier application number: M017
BODY ACTION PRODUCTS Climax Control Gel	BENZOCAINE	PRODUCT MAX GROUP INC	53e746cc-0078-4381-bf0b-9c8f98d66904	2023-11-10	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