FDA.reportPublic FDA data

Anti-Itch Cream

Product NDC
69396-025
11-digit product format
693960025
Labeler code
69396
Product ID
69396-025_0df7f83e-5adb-ec48-e063-6294a90a198e
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride 2%, zinc acetate 0.1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA, LLC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-12-29
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
Anti-Itch Cream
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
44d17651-a31b-64ca-e054-00144ff8d46cAvailable 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
69396-025-05Anti-Itch Cream1 in 1 BOXCREAM15
69396-025-05Anti-Itch Cream15 g in 1 TUBECREAM155
69396-025-15Anti-Itch Cream42 g in 1 TUBECREAM425
69396-025-15Anti-Itch Cream1 in 1 BOXCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-025-05GM - Gram69396-0250632feb3-c28a-47f3-9ffc-ea4d7c5dc36212018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-025ANTI-ITCH CREAM (DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%) CREAM [TRIFECTA PHARMACEUTICALS USA, LLC.]5Current NDC, Legacy NDC, 4 package rows20240103_44d17651-a31b-64ca-e054-00144ff8d46c.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 111 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEMeijer Distribution Inc75c6fcd5-185c-4203-b604-19ce801c865f2024-12-18WarningsExact identifier
application number: M017
MEIJER PAIN RELIEF PATCHESLIDOCAINEMeijer Distribution Incaa5da66d-3ba9-4120-be35-44bec475761a2024-12-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%CVS Pharmacy8a9757e3-0bfc-a1e2-e053-2a95a90a6da32024-12-18WarningsExact identifier
application number: M017
Dollar General Cold-Hot Medicated PatchesMENTHOLDOLGENCORP, LLCc6e0388b-af9e-4e51-8f94-6788185c31a02024-12-18WarningsExact identifier
application number: M017
THERA CARE PAIN THERAPYLIDOCAINEVeridian Healthcaree023bb5a-a4bc-4681-a1f4-48ca0d2cb1022024-12-18WarningsExact identifier
application number: M017
TheraCare Medicated Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEVeridian Healthcaref6f3c9c0-d6e3-75a3-e053-6294a90a19652024-12-18WarningsExact identifier
application number: M017
Good Sense Hot and Cold Medicated PatchMENTHOLGOOD SENSE1b16c3e5-a29f-4043-94e6-0a0e0ea3d93e2024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFEf2ef9c12-6e42-486b-b6f2-0ad534e942942024-12-18WarningsExact identifier
application number: M017
Hunter Beach 4%LIDOCAINEHUNTERS BEACH LIFE05a9605b-0d01-4333-8e54-7202e7c31c492024-12-18WarningsExact identifier
application number: M017
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
application number: M017
WellPatch Warming Pain ReliefCAPSAICINThe Mentholatum Companyec583129-55fc-4ab1-94e5-9c900b5d95ef2024-12-17WarningsExact identifier
application number: M017
CVS Health Cold and Hot Pain Relieving Extra StrengthMENTHOL, METHYL SALICYLATECVS Pharmacy1ca1a631-cb2c-46cd-bd41-05469b08d2082024-12-17WarningsExact identifier
application number: M017
Mentholatum Pain RelievingMENTHOL, METHYL SALICYLATEThe Mentholatum Company0056b952-9870-485a-9f35-f985472875a92024-12-17WarningsExact identifier
application number: M017
Mentholatum Lidocaine HeatLIDOCAINE HCLThe Mentholatum Companycc2ef25a-b569-4d48-a666-899f710b4b342024-12-17WarningsExact identifier
application number: M017
Rite Aid Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATERite Aid Corporation039fff40-b5ba-42cb-932c-8a70ca92759d2024-12-17WarningsExact identifier
application number: M017
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
application number: M017
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
application number: M017
Equate Capsaicin Pain RelievingCAPSAICINWal-Mart Stores Inc745b2cf5-2599-4383-818b-19fed248a11f2024-12-17WarningsExact identifier
application number: M017
CVS Health Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a2024-12-17WarningsExact identifier
application number: M017
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087026diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical CreamPSN44d17651-a31b-64ca-e054-00144ff8d46c5
1087026diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical CreamSCD44d17651-a31b-64ca-e054-00144ff8d46c5
1087026diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical CreamSY44d17651-a31b-64ca-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-025-05693960025051 TUBE in 1 BOX (69396-025-05) / 15 g in 1 TUBE1 tube2016-12-290000-00-00NoNoCurrent
69396-025-15693960025151 TUBE in 1 BOX (69396-025-15) / 42 g in 1 TUBE1 tube2020-02-110000-00-00NoNoCurrent