FDA.reportPublic FDA data

Itch Relief

Product NDC
42507-986
11-digit product format
425070986
Labeler code
42507
Product ID
42507-986_48351702-9a78-74f8-e063-6394a90aa1a5
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl, Zinc Acetate
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
HY-VEE, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-13
Substance
ZINC ACETATE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1; 20 mg/g; mg/g
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
Itch Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC ACETATE1 mg/g
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FM5526K07AInternal UNII lookup
TC2D6JAD40Internal 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
48350b54-8d9a-48c4-e063-6394a90ac040Available 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
42507-986-76Itch Relief76 g in 1 CANISTERAEROSOL, SPRAY761

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 138 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MED O-3 BIO-METHYL SALICYLATE, MENTHOL, CAPSAICINBiological M.D. Solutions LLC02707552-03d9-3ad2-e063-6294a90a34722024-01-06WarningsExact identifier
application number: M017
Sumifun Knee Relieving PatchKNEE RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e7e73ec-ab33-9235-e063-6394a90ad9502024-01-06WarningsExact identifier
application number: M017
Lidocaine Numbing CreamLIDOCAINEYYBA Corpde6dc194-c6ef-4cb5-be3f-e772ace9abaf2024-01-03WarningsExact identifier
application number: M017
Equate Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMWalmart Inc.0cdc9323-f5c3-468c-a7ae-83dfd2d766262024-01-03WarningsExact identifier
application number: M017
OWELL NATURALS Deep Penetrating Pain ReliefMENTHOLOWELL NATURALS BRAND, LLCb36eb017-ed8d-476e-994b-22b275e005432024-01-02WarningsExact identifier
application number: M017
DibucaineDIBUCAINE 1%Trifecta Pharmaceuticals USA LLCe8a56651-a292-7609-e053-2a95a90a7c362024-01-02WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Trifecta Pharmaceuticals USA, LLC.44d17651-a31b-64ca-e054-00144ff8d46c2024-01-02WarningsExact identifier
application number: M017
Muscle Rub CreamMENTHOL 10%, METHYL SALICYLATE 15%Trifecta Pharmaceuticals USA, LLC.e0a13344-5493-eb51-e053-2995a90a81832024-01-02WarningsExact identifier
application number: M017
Sumifun Knee Relieve PatchKNEE RELIEVE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0e031aa5-edf4-8c9d-e063-6394a90afee32024-01-02WarningsExact identifier
application number: M017
OKeeffes Healthy FeetALLANTOIN, LIDOCAINEThe Gorilla Glue Company/O'Keeffe's Companyd73709db-3932-3c56-e053-2995a90a7d0a2024-01-01WarningsExact identifier
application number: M017
PERSONAL CARE ICE COLDMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.1994356c-e347-5b7d-e063-6394a90a476c2024-01-01WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINProficient Rx LP7e765fc1-74c6-4af3-a9cf-05b57011d7d82024-01-01WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Incc6a0880e-fc16-46e9-8314-c56c9d15bf312023-12-31WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Anti ItchHYDROCORTISONEL'Oreal USA Products Inc.8d65e945-2557-486f-9279-ecbaa08f31c42023-12-31WarningsExact identifier
application number: M017
Nighttime Sleep-Aid Non-Habit FormingDIPHENHYDRAMINE HCIAptaPharma Inc.ed0ba7aa-e794-43da-b576-6b9945bf74772023-12-30WarningsExact identifier
application number: M017
Sting-KillBENZOCAINE AND MENTHOLRANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTHb8bd9280-f20a-4b2a-aef7-a0ba7b3b87012023-12-29WarningsExact identifier
application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated BalmMENTHOLL'Oreal USA Products Inc2f7b8221-66f6-4aed-8359-318cfc656a722023-12-28WarningsExact identifier
application number: M017
Equate CortisoneHYDROCORTISONE 1%Walmart Inc027fae33-93a0-a61f-e063-6294a90a990f2023-12-27WarningsExact identifier
application number: M017
Walgreens Cool n Heat LidocaineLIDOCAINE HCL 4%Walgreens Co0681c6c5-5a8b-ea9e-e063-6394a90a83bc2023-12-27WarningsExact identifier
application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEFDIPHENHYDRAMINE, ZINC ACETATEWALGREEN CO681cf1af-2cc3-4e6d-b76f-f00731ea3e122023-12-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN48350b54-8d9a-48c4-e063-6394a90ac0401
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD48350b54-8d9a-48c4-e063-6394a90ac0401
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY48350b54-8d9a-48c4-e063-6394a90ac0401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-986-764250709867676 g in 1 CANISTER (42507-986-76) 76 g2026-01-12NoNoCurrent