FDA.reportPublic FDA data

diphenhydramine hcl and zinc acetate

Product NDC
45802-358
11-digit product format
458020358
Labeler code
45802
Product ID
45802-358_888ad1f9-aeb1-4778-8d5a-734e734036e6
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2005-12-05
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength
2; .1 g/100g; g/100g
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
diphenhydramine hcl and zinc acetate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100g
ZINC ACETATE.1 g/100g

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
6d7a7615-9ae7-4c55-8a84-dba746f535d7Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-358-03diphenhydramine hcl and zinc acetate1 in 1 CARTONCREAM17
45802-358-03diphenhydramine hcl and zinc acetate28 g in 1 TUBECREAM287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-358-03GM - Gram45802-3585ee96519-a817-4023-a42d-f209f5a5fe7212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
ZINC ACETATEACTIVE INGREDIENTFM5526K07ADIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
ZINCACTIVE MOIETYJ41CSQ7QDSDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
PEG-2 STEARATEINACTIVE INGREDIENT94YQ11Y95FDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
PEG-20 STEARATEINACTIVE INGREDIENTNBX892EA57DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2
WATERINACTIVE INGREDIENT059QF0KO0RDIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PERRIGO NEW YORK INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-358DIPHENHYDRAMINE HCL AND ZINC ACETATE (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 2 package rows20240830_6d7a7615-9ae7-4c55-8a84-dba746f535d7.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 62 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC04b1d605-60aa-56f4-e063-6294a90ae7602025-11-17WarningsExact identifier
application number: M017
AY BENDITO - CBDCAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INC0f1406fe-3a2f-bf36-e063-6294a90a7e5e2025-11-17WarningsExact identifier
application number: M017
AY BENDITO CBDMENTHOL, CAMPHORAY BENDITO INTERNATIONAL, INC30a1c6b7-e37e-32c2-e063-6394a90aa3542025-11-17WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS WITH CBD 3000MENTHOL, CAMPHORWorldwide Cosmetics, Inc0816cc8f-8d0b-de27-e063-6294a90a8a9d2025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLCf6538e3e-4663-679c-e053-2995a90a87b52025-11-17WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLCf65455d7-04a9-6217-e053-2995a90a7c902025-11-17WarningsExact identifier
application number: M017
JUST CBD - CBD AND THC ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLCf664eb79-8897-3a49-e053-2995a90a37b42025-11-17WarningsExact identifier
application number: M017
JUST CBD RELIEF SOOTHINGLIDOCAINE HCLJust Brands LLCf9aff6e7-5702-f61c-e053-6294a90aa66f2025-11-17WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC0abece07-976c-4881-e063-6294a90a5c1b2025-11-17WarningsExact identifier
application number: M017
Blue-Emu Thrive Pain Relief CreamTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLCa4ba6787-c99b-4bf2-9f8f-e923ef9762122025-11-14WarningsExact identifier
application number: M017
CVS Cooling PatchMENTHOLCVS Pharmacy42d97e29-f32d-a31b-e063-6394a90a88d82025-11-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
application number: M017
EXTREME EMUMENTHOL, METHYL SALICYLATERenu Laboratories, LLC4393b57b-1e70-b8dd-e063-6294a90ae7482025-11-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN6d7a7615-9ae7-4c55-8a84-dba746f535d77
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD6d7a7615-9ae7-4c55-8a84-dba746f535d77
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY6d7a7615-9ae7-4c55-8a84-dba746f535d77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-358-03458020358031 TUBE in 1 CARTON (45802-358-03) / 28 g in 1 TUBE1 tube2005-12-050000-00-00NoNoCurrent