FDA.reportPublic FDA data

leader anti itch

Product NDC
70000-0388
11-digit product format
700000388
Labeler code
70000
Product ID
70000-0388_62cd1143-2372-499e-a76f-1a562170eaec
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride, Zinc Acetate
Dosage form
CREAM
Route
TOPICAL
Labeler
Cardinal Health 110, LLC. dba Leader
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-12-13
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
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
leader anti itch
Listing expiration
2026-12-31

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
e1aab35b-80d9-4515-afb7-8c662bc5d028Available 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
70000-0388-1leader anti itch1 in 1 CARTONCREAM15
70000-0388-1leader anti itch28 g in 1 TUBECREAM285

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0388-1GM - Gram70000-0388e3e4d0f0-a824-41da-a26d-26e88e509a2112019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0388LEADER ANTI ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE) CREAM [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 2 package rows20240913_e1aab35b-80d9-4515-afb7-8c662bc5d028.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 49 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Maximum OTC Strength Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)0e9a711c-ddf4-af63-e063-6294a90a0ebe2025-12-29WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEHarris Teeter3f5b4eee-49c4-408c-9af2-e7924c26ac632025-12-29WarningsExact identifier
application number: M017
talc-free medicated bodyMENTHOLDavion, Inc27b9b4dc-4d4f-4e9d-b388-a7c6807a0e9b2025-12-29WarningsExact identifier
application number: M017
H-E-B Medicated Corn Starch Foot PowderMENTHOLDavion, Inca6675e00-bc6b-4466-a283-4cece5f919702025-12-29WarningsExact identifier
application number: M017
Maximum Strength Medicated Foot PowderMENTHOLDavion, Inc7b442d99-ac19-4f65-828d-954c5350ef5a2025-12-29WarningsExact identifier
application number: M017
HEB Medicated Cornstarch Body PowderMENTHOLDavion, Incdf1331fb-48df-4f21-8564-0468078fd12d2025-12-29WarningsExact identifier
application number: M017
Honest Med Capsaicin PatchCAPSAICINProper Buys LLC30169d44-b1b2-5c0f-e063-6294a90ae1592025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Lavender Roll-onLIDOCAINE HCLProper Buys LLC2dcd40a9-3fdd-a71e-e063-6294a90a704f2025-12-28WarningsExact identifier
application number: M017
Honest Med Lidocaine Pain Relief PatchLIDOCAINEProper Buys LLC13a5243f-7116-e4da-e063-6394a90aa5432025-12-28WarningsExact identifier
application number: M017
CVS Health Pain-Relieving PatchMENTHOL, METHYL SALICYLATE, CAMPHORCVS Pharmacy, Inc.1f90899c-eeca-2362-e063-6294a90aa0da2025-12-28WarningsExact identifier
application number: M017
CVS Health Cooling PatchMENTHOLCVS Pharmacy, Inc1f90cefe-bcce-5e17-e063-6294a90a57362025-12-28WarningsExact identifier
application number: M017
Point Relief LidoSpot with MentholLIDOCAINE, MENTHOLFabrication Enterprisesf0c69693-bfea-4006-9620-63b222d25d382025-12-28WarningsExact identifier
application number: M017
DISCOUNT DRUG MART PAIN RELIEF PATCHESLIDOCAINEDiscount Drug Mart, Ince36e7d0a-d554-4601-b535-b41ee84a6b242025-12-28WarningsExact identifier
application number: M017
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEDiscount Drug Mart, Incc01e1a14-bfbc-4c52-8a67-b77acf2d88532025-12-28WarningsExact identifier
application number: M017
TopCare Pain Relief PatchLIDOCAINE, MENTHOLTopco Associates LLCd4c89c4f-d69a-7786-e053-2995a90a71e72025-12-28WarningsExact identifier
application number: M017
Kroger Lidocaine Pain RelievingLIDOCAINE HCLKroger Company12d94ba6-56ac-3816-e063-6394a90a44c62025-12-28WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEAhold U.S.A., Inc,7e7a813e-424d-4a78-9c72-541c3c62606a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Cold and Hot Medicated PatchMENTHOLAmazon.com Services LLCe3b4db12-c846-b984-e053-2a95a90a8e9a2025-12-28WarningsExact identifier
application number: M017
Amazon Basics Pain Relief Patch with 4% LidocaineLIDOCAINEAmazon.com Services LLCe3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e2025-12-28WarningsExact identifier
application number: M017
Absorbine Jr Neck and ShoulderABSORBINE JR NECK AND SHOULDERClarion Brands LLC22f2f191-9146-3075-e063-6394a90aef5f2025-12-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSNe1aab35b-80d9-4515-afb7-8c662bc5d0285
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCDe1aab35b-80d9-4515-afb7-8c662bc5d0285
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSYe1aab35b-80d9-4515-afb7-8c662bc5d0285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0388-1700000388011 TUBE in 1 CARTON (70000-0388-1) / 28 g in 1 TUBE1 tube2018-12-130000-00-00NoNoCurrent