FDA.reportPublic FDA data

Dermachange Aid Anti-Itch

Product NDC
83520-107
11-digit product format
835200107
Labeler code
83520
Product ID
83520-107_12ed906c-d027-0ff7-e063-6394a90aaa52
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Private Label Beauty and Wellness
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-31
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
2 g/100mL
Pharmacologic classes
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
Dermachange Aid Anti-Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049880Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
12ed906c-d028-0ff7-e063-6394a90aaa52Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83520-107-03Dermachange Aid Anti-Itch104 mL in 1 TUBEGEL1041

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83520-107DERMACHANGE AID ANTI-ITCH (DIPHENHYDRAMINE HCL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS]1Current NDC, 1 package rows20240307_12ed906c-d028-0ff7-e063-6394a90aaa52.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 79 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY27679d31-a5f3-417b-b0c5-5f6b001ecff92025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM52fff03e-eba2-4604-a71c-2522468f627b2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde210c3a-c24e-cefd-e053-2a95a90a93ff2025-09-02WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, CAMPHOR, CAPSAICINAHC VENTURES CORP DBA CRY799751f3-726a-42de-934e-dbc3cd1cb8b82025-09-02WarningsExact identifier
application number: M017
Pain Relieving Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERMde0c9a73-dbc0-599e-e053-2a95a90a79862025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC VENTURES CORP DBA CRYODERM90334420-5f81-4284-9a57-42e134ce362f2025-09-02WarningsExact identifier
application number: M017
KNEE PAIN RELIRF PatchCAMPHOR, MENTHOLShenzhen Finona Information Technology Co., Ltd3db971ef-d7fa-0171-e063-6294a90aa58b2025-09-01WarningsExact identifier
application number: M017
Bikini Zone Medicated CremeLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC300ac57e-844a-4840-b285-41ff5518e6b62025-08-29WarningsExact identifier
application number: M017
Bikini Zone Medicated GelLIDOCAINEKingsway Pharmaceuticals dba NFI, LLC30b85890-e72d-4af7-bda9-e7744abc92af2025-08-29WarningsExact identifier
application number: M017
Sumifun Lidocaine Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd3d7dc8cc-0680-d94d-e063-6394a90ac8e82025-08-29WarningsExact identifier
application number: M017
TKTALKER NUMBINGNUMBINGShenzhen Shandian Jingling Technology Co., Ltd.3d7e6757-f183-2a68-e063-6294a90ae4ca2025-08-29WarningsExact identifier
application number: M017
PBZ OTCTRIPELENNAMINE HCL 1%Kingsway Pharmaceuticals dba NFI, LLC12f72d74-018f-4bc6-acd4-175ca3af4c6d2025-08-29WarningsExact identifier
application number: M017
else.LIDOCAINEElse Co.3d6c7b10-ed03-bbde-e063-6294a90ae92f2025-08-28WarningsExact identifier
application number: M017
Mountain Ice Pain ReliefMENTHOLMountainside Medical Equipment, Inc.c79fdd91-16f4-4ae0-bee4-d37c05ed20742025-08-28WarningsExact identifier
application number: M017
HealthWise 4% Lidocaine Cream 2.7 ozLIDOCAINE HYDROCHLORIDEVeridian Healthcaref39eb3d0-e153-4f50-85b1-ad5c677d176c2025-08-28WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN12ed906c-d028-0ff7-e063-6394a90aaa521
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD12ed906c-d028-0ff7-e063-6394a90aaa521
1049880diphenhydramine hydrochloride 2 % Topical GelSY12ed906c-d028-0ff7-e063-6394a90aaa521

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83520-107-0383520010703104 mL in 1 TUBE (83520-107-03) 104 ml2024-01-31NoNoCurrent