FDA.reportPublic FDA data

Diphenhydramine Hydrochloride and Zinc Acetate

Product NDC
70677-1213
11-digit product format
706771213
Labeler code
70677
Product ID
70677-1213_4c21745b-806a-28f7-e063-6394a90a352c
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride and Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-13
Marketing end
2027-02-28
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
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 Hydrochloride and Zinc Acetate

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
ec0c9602-35cc-4bb6-b853-794a8b5bf42eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
70677-1213-1Diphenhydramine Hydrochloride and Zinc Acetate1 in 1 CARTONCREAM15
70677-1213-1Diphenhydramine Hydrochloride and Zinc Acetate28.4 g in 1 TUBECREAM28.45

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1213-1GM - Gram70677-12138aeead10-9ded-4b37-9f64-cf1e7a6f7cc912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1213DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAM [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 2 package rows20231222_ec0c9602-35cc-4bb6-b853-794a8b5bf42e.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 59 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc7d4e21d1-2914-4690-9084-a52abeab09582025-12-02WarningsExact identifier
application number: M017
Rugby Capsaicin CreamCAPSAICINRugby Laboratories9eca34f1-e91a-3ac1-e053-2a95a90a9bd92025-12-02WarningsExact identifier
application number: M017
Leader Capsaicin Pain Relief CreamCAPSAICINCardinal Health 110 dba LEADERa5620709-0fed-4979-e053-2a95a90ac6542025-12-02WarningsExact identifier
application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsExact identifier
application number: M017
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsExact identifier
application number: M017
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ONCAMPHORSUNSET NOVELTIES, INC45048936-f3c9-25f7-e063-6394a90ac4a92025-12-02WarningsExact identifier
application number: M017
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
application number: M017
CareALL Arthritis and MuscleCAPSAICINNew World Imports, Inc4867eac4-00ea-434e-b289-1c1ef0342c232025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNec0c9602-35cc-4bb6-b853-794a8b5bf42e5
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDec0c9602-35cc-4bb6-b853-794a8b5bf42e5
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYec0c9602-35cc-4bb6-b853-794a8b5bf42e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70677-1213-1706771213011 TUBE in 1 CARTON (70677-1213-1) / 28.4 g in 1 TUBE1 tube2023-12-132027-02-28NoNoHistorical