FDA.reportPublic FDA data

Diphenhydramine HCl and Zinc Acetate

Product NDC
41250-058
11-digit product format
412500058
Labeler code
41250
Product ID
41250-058_2479e274-3585-44d6-e063-6394a90a7810
Type
HUMAN OTC DRUG
Nonproprietary name
Extra Strength Itch Relief
Dosage form
SPRAY
Route
TOPICAL
Labeler
Meijer Distribution Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-15
Marketing end
2027-05-31
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
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 HYDROCHLORIDE1.52 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
18998e1c-1254-4d0c-93f1-26652c5ca076Available 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
41250-058-30Diphenhydramine HCl and Zinc Acetate76 g in 1 CANSPRAY7611

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
ZINC CATIONACTIVE MOIETY13S1S8SF37DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-058DIPHENHYDRAMINE HCL AND ZINC ACETATE (EXTRA STRENGTH ITCH RELIEF) SPRAY [MEIJER DISTRIBUTION INC]11Current NDC, Legacy NDC, 1 package rows20241016_18998e1c-1254-4d0c-93f1-26652c5ca076.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 55 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact identifier
application number: M017
Careland Pain Relief PlusCAMPHOR, MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.d9e63ddd-d003-45fa-b156-7f4452c28cbd2025-12-12WarningsExact identifier
application number: M017
Glucosamine Cream EXTRA STRENGTHHISTAMINE DIHYDROCHLORIDEIDEAZ, LLCf4d414b7-89e7-ad65-e053-2a95a90a25d42025-12-12WarningsExact identifier
application number: M017
ARTHRITISMENTHOLSmith Amish, LLC20c36972-b695-1241-e063-6394a90adf632025-12-12WarningsExact identifier
application number: M017
FOOTMENTHOLSmith Amish, LLC20c48537-f55f-c10f-e063-6394a90a4cca2025-12-12WarningsExact identifier
application number: M017
Joint EaseMENTHOLSmith Amish, LLC20c4a0f8-bdc6-d89a-e063-6294a90aa8d82025-12-12WarningsExact identifier
application number: M017
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
application number: M017
Lidospot patchLIDOCAINE AND MENTHOLFabrication Enterprises Inc3a6e94c4-1ca6-e77a-e063-6394a90a4bfc2025-12-12WarningsExact identifier
application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feetMENTHOLGuangdong Aimu Biological Technology Co., Ltd45a99afc-15ec-76c2-e063-6294a90a22202025-12-11WarningsExact identifier
application number: M017
CintheraLIDOCAINEStrand Health Group2746e5b2-be2d-f2d2-e063-6394a90a36902025-12-11WarningsExact identifier
application number: M017
Equate Cool and Heat Pain Relieving LiquidCOOL AND HEAT PAIN RELIEFWalmart, Inc.ad156685-3bd5-6837-e053-2995a90ac7882025-12-11WarningsExact identifier
application number: M017
HUMCO Camphor SpiritCAMPHOR 10%Humco Holding Group, Inc.9a0ef0a3-3c79-41b2-8193-424a3ef9886f2025-12-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1053138diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical SprayPSN18998e1c-1254-4d0c-93f1-26652c5ca07611
1053138diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical SpraySCD18998e1c-1254-4d0c-93f1-26652c5ca07611
1053138diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical SpraySY18998e1c-1254-4d0c-93f1-26652c5ca07611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-058-304125000583076 g in 1 CAN (41250-058-30) 76 g2015-09-152027-05-31NoNoCurrent