FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
49035-015
11-digit product format
490350015
Labeler code
49035
Product ID
49035-015_38917a94-449f-7050-e063-6394a90a0245
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-Itch Continuous Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-03-03
Marketing end
2026-10-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1.5; .075 g/88mL; g/88mL
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
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE1.5 g/88mL
ZINC ACETATE.075 g/88mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup
FM5526K07AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1053138Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
709c3bb8-5b36-4823-941a-45ddb3e431c4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-015-03Diphenhydramine HCl and Zinc Acetate88 mL in 1 CANISTERAEROSOL, SPRAY889

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-015DIPHENHYDRAMINE HCL AND ZINC ACETATE (ANTI-ITCH CONTINUOUS SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]8Current NDC, Legacy NDC, 1 package rows20241109_709c3bb8-5b36-4823-941a-45ddb3e431c4.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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL BREEZE Pain ReliefMENTHOLCOOL BREEZE US LLC14dcf4ee-6778-49d4-8601-9205737432ea2023-11-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP1ebb45e5-4541-4c95-abe1-661ef763a6102023-11-01WarningsExact identifier
application number: M017
Walgreens Pain Relieving CreamLIDOCAINE 4%Walgreensce1b55ed-f5c5-ea8b-e053-2a95a90acd402023-10-31WarningsExact identifier
application number: M017
Walgreens pain relievingLIDOCAINE 4%Walgreensce2b9e57-749d-715c-e053-2995a90aaf8d2023-10-31WarningsExact identifier
application number: M017
Walgreens Cool n heatLIDOCAINE 4% MENTHOL 1%Walgreensce168ab7-ec4a-daea-e053-2995a90af8292023-10-31WarningsExact identifier
application number: M017
Methyl Salicylate 40 PercentMETHYL SALICYLATEAlexso, Inc53407aab-094c-4393-a2b9-54fd85321e3e2023-10-31WarningsExact identifier
application number: M017
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN709c3bb8-5b36-4823-941a-45ddb3e431c49
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD709c3bb8-5b36-4823-941a-45ddb3e431c49
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY709c3bb8-5b36-4823-941a-45ddb3e431c49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-015-034903500150388 mL in 1 CANISTER (49035-015-03) 88 ml2013-03-032026-10-31NoNoCurrent