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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact 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