FDA.reportPublic FDA data

Bite and Itch

Product NDC
11383-192
11-digit product format
113830192
Labeler code
11383
Product ID
11383-192_28650b5a-ed6f-199c-e063-6394a90a9dac
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride, Pramoxine Hydrochloride
Dosage form
LOTION
Route
CUTANEOUS
Labeler
Weeks & Leo Co., Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-15
Substance
PRAMOXINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
1; 2 g/100mL; 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
Bite and Itch
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PRAMOXINE HYDROCHLORIDE1 g/100mL
DIPHENHYDRAMINE HYDROCHLORIDE2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
88AYB867L5Internal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1292321Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a4d471b-c3f3-0a6a-e063-6394a90ad57bAvailable 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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-192-01Bite and Itch118 mL in 1 BOTTLELOTION1183
11383-192-01Bite and Itch1 in 1 CARTONLOTION13
11383-192-04Bite and Itch118 mL in 1 BOTTLELOTION1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-192BITE AND ITCH (DIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) LOTION [WEEKS & LEO CO., INC.]3Current NDC, 3 package rows20241206_0a4d471b-c3f3-0a6a-e063-6394a90ad57b.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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1292321diphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical LotionPSN0a4d471b-c3f3-0a6a-e063-6394a90ad57b3
1292321diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical LotionSCD0a4d471b-c3f3-0a6a-e063-6394a90ad57b3
1292321diphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical LotionSY0a4d471b-c3f3-0a6a-e063-6394a90ad57b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11383-192-01113830192011 BOTTLE in 1 CARTON (11383-192-01) / 118 mL in 1 BOTTLE1 bottle2015-06-15NoNoCurrent
11383-192-0411383019204118 mL in 1 BOTTLE (11383-192-04) 118 ml2015-06-15NoNoCurrent