FDA.reportPublic FDA data

Itch Relief

Product NDC
13709-351
11-digit product format
137090351
Labeler code
13709
Product ID
13709-351_44811828-c32f-17fc-e063-6294a90add48
Type
HUMAN OTC DRUG
Nonproprietary name
Itch Relief Gel
Dosage form
GEL
Route
TOPICAL
Labeler
Neilmed Pharmaceuticals Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
20 mg/mL
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
Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE20 mg/mL

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
44811828-c32e-17fc-e063-6294a90add48Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-351-01Itch Relief1 in 1 CARTONGEL11
13709-351-01Itch Relief103.5 mL in 1 TUBEGEL103.51

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 147 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum Aerobic SportsSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC33f2491e-c1f2-4e5a-acbe-8ace844b88d62023-11-09WarningsExact identifier
application number: M017
Valtrum Topical Analgesic Roll OnSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC28167e2a-9afb-44e7-90c7-9577df9504b62023-11-09WarningsExact identifier
application number: M017
Satohap Cool TypeCAMPHOR, MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.fe07a00a-2699-44d3-887d-bd068948ad7b2023-11-07WarningsExact identifier
application number: M017
Hims Delay WipesBENZOCAINE WIPESHims Inc.adbead3d-dca0-4919-b688-44c88f779e5a2023-11-07WarningsExact identifier
application number: M017
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
application number: M017
Arth RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and LavenderHISTAMINE DIHYDROCHLORIDEBAKER'S BEST HEALTH PRODUCTS, INC.03ec87c5-6669-4afb-8d9c-c8dc9907495d2023-11-06WarningsExact identifier
application number: M017
DOCTORS TOUCH Erase The PainMENTHOLDOCTOR'S CHOICE MEDICAL, LLCfe9ce2c7-d6af-4dad-b6e6-5049a9e091b02023-11-06WarningsExact identifier
application number: M017
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN44811828-c32e-17fc-e063-6294a90add481
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD44811828-c32e-17fc-e063-6294a90add481
1049880diphenhydramine hydrochloride 2 % Topical GelSY44811828-c32e-17fc-e063-6294a90add481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13709-351-01137090351011 TUBE in 1 CARTON (13709-351-01) / 103.5 mL in 1 TUBE1 tube2025-11-26NoNoCurrent