FDA.reportPublic FDA data

ItchZap

Product NDC
57237-352
11-digit product format
572370352
Labeler code
57237
Product ID
57237-352_efed5317-cd02-4fe0-8287-f5a763dd4736
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Rising Pharma Holdings, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-06
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
20; 1 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
2026-12-31
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
ItchZap
Listing expiration
2026-12-31

Active Ingredients#

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

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
1087026Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
245d0afb-19a8-4cfb-968b-d892b18d5f2cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-352-28ItchZap1 in 1 CARTONCREAM11
57237-352-28ItchZap28 g in 1 TUBECREAM281

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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN245d0afb-19a8-4cfb-968b-d892b18d5f2c1
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD245d0afb-19a8-4cfb-968b-d892b18d5f2c1
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY245d0afb-19a8-4cfb-968b-d892b18d5f2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-352-28572370352281 TUBE in 1 CARTON (57237-352-28) / 28 g in 1 TUBE1 tube2025-11-06NoNoCurrent