FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
37808-526
11-digit product format
378080526
Labeler code
37808
Product ID
37808-526_42653e08-8894-9563-e063-6394a90a5e77
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief
Dosage form
SPRAY
Route
TOPICAL
Labeler
HEB
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-22
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
1.52; .076 g/76g; g/76g
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
Diphenhydramine HCl and Zinc Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE1.52 g/76g
ZINC ACETATE.076 g/76g

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
2aedbf1d-c8b7-4d5d-83ee-e38872c37d4fAvailable 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
37808-526-27Diphenhydramine HCl and Zinc Acetate76 g in 1 CANSPRAY767

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-526DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [HEB]6Current NDC, Legacy NDC, 1 package rows20241212_2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f.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 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M017
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
application number: M017
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
application number: M017
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
application number: M017
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
application number: M017
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Climax Control GelBENZOCAINEPRODUCT MAX GROUP INC53e746cc-0078-4381-bf0b-9c8f98d669042023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Endless Love for MenBENZOCAINEPRODUCT MAX GROUP INCd0fa792d-dc04-4bdf-a22d-dea896beae5b2023-11-10WarningsExact identifier
application number: M017
Endless Love For MenBENZOCAINEBody Action Products, Inc4e89cd3a-ecad-44c3-acb3-6d0810add8c02023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Higher Control Male ClimaxBENZOCAINEPRODUCT MAX GROUP INC3c7fa73b-abe8-4a8d-951c-4e785d6e812c2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC65a319a6-89d2-44c9-81d5-30327f9948cb2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC768f3f0e-1add-404f-b869-00a9f35ad34a2023-11-10WarningsExact identifier
application number: M017
Zcaine Fast Acting AnestheticLIDOCAINEPHI, Incd072243f-6ba6-4ab6-8ebf-a2381fa9c2df2023-11-09WarningsExact identifier
application number: M017
Plum Smooth Plumb Numb GeleeLIDOCAINEUniversal Companies, Inc.6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e2023-11-09WarningsExact identifier
application number: M017
Sonacaine Topical Anesthetic With MentholLIDOCAINEFilltech USA, LLCca54c6da-4bf2-4e63-ba7f-a69c4f9c431a2023-11-09WarningsExact identifier
application number: M017
Bed Bug Instant Bite ReliefLIDOCAINEP.F. Harris Mfg. Co. LLC7f472fd0-5605-4cc6-b4b2-1267e815255c2023-11-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-526-273780805262776 g in 1 CAN (37808-526-27) 76 g2017-12-220000-00-00NoNoCurrent