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 65 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Cold As Ice Pain ReliefMENTHOLTelebrands Corp95e84bb9-ba2e-5009-e053-2995a90a43622025-11-12WarningsExact identifier
application number: M017
LidozallLIDOCAINE HYDROCHLORIDEV2 Pharma LLC1eb2dfb2-3ad1-488b-aed9-17220e34a10c2025-11-12WarningsExact identifier
application number: M017
Lidozall PlusLIDOCAINE HYDROCHLORIDEV2 Pharma LLCba3cbb15-f4ed-443e-af43-a758481acb0b2025-11-12WarningsExact identifier
application number: M017
Knee Pain Relief PatchDL-CAMPHOR, L-MENTHOL, METHYL SALICYLATEShenzhen Finona Information Technology Co., Ltd38755738-1a06-fdb4-e063-6294a90aa6eb2025-11-12WarningsExact identifier
application number: M017
Recovery NumbLIDOCAINE 4%PURKLENZ FORMULATIONS INC.e95e38e3-f743-4f5c-abdf-99ba6856e6f72025-11-12WarningsExact identifier
application number: M017
Rapid ReliefCOLD RELIEF PATCH 5% MENTHOLRAPID AID VIET NAM COMPANY LIMITED434c13c2-52ee-000f-e063-6294a90af7e72025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MGRAPID AID VIET NAM COMPANY LIMITED434d5f92-05c2-d884-e063-6394a90ad28c2025-11-11WarningsExact identifier
application number: M017
Rapid ReliefPAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%RAPID AID VIET NAM COMPANY LIMITED434df0be-49ff-aa56-e063-6394a90a3b5a2025-11-11WarningsExact identifier
application number: M017
TopCare Pain Relief Maximum StrengthLIDOCAINE HYDROCHLORIDETOPCO ASSOCIATESb0ae3a7c-52d1-4923-bd50-6bb3749006c82025-11-11WarningsExact identifier
application number: M017
ComfortcaineLIDOCAINE HCLQS Key West Aloe, LLC831b7c11-e437-4e74-808e-c9c1eb8b82f62025-11-11WarningsExact identifier
application number: M017
A and E Marathon Delay SerumDELAY SERUMPhe Inc4355d1d8-44fe-aca1-e063-6294a90a85ff2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayStrawberryORAL NUMBING SPRAY STRAWBERRYPhe Inc4355dab1-a293-ded6-e063-6394a90af9b02025-11-11WarningsExact identifier
application number: M017
A and E Easy Anal GelANAL NUMBING LUBRICANTPhe Inc4355e0f3-65ba-eca6-e063-6394a90ab43c2025-11-11WarningsExact identifier
application number: M017
A and E Deep Throat Desensitizing SprayPeppermintORAL NUMBING SPRAY MINTPhe Inc4355e0d0-1222-d594-e063-6294a90abb292025-11-11WarningsExact identifier
application number: M017
DermaNumb AnalgesicLIDOCAINE HCLA.T.S. Laboratories, LLC0ea46890-45c3-4732-bc47-227f7c67daf12025-11-11WarningsExact identifier
application number: M017
Derma Numb Pain ReliefLIDOCAINE HCLA.T.S. Laboratories, LLC710991ae-8f82-4893-93a7-0ef3f815d1322025-11-11WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEEncube Ethicals, Inc.969cd576-82d3-4662-bbc1-3587a1f6a5642025-11-10WarningsExact identifier
application number: M017
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anestheticc6e86a0f-6f9b-45b7-86ce-0bb1c198061a2025-11-10WarningsExact identifier
application number: M017
Hush AnestheticLIDOCAINEHUSH Anesthetic97ae1993-7268-4b7f-92e2-6004337d56502025-11-10WarningsExact 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