FDA.reportPublic FDA data

BiteMD

Product NDC
68093-9561
11-digit product format
680939561
Labeler code
68093
Product ID
68093-9561_4f860c1e-a639-4923-e063-6294a90ae7e2
Type
HUMAN OTC DRUG
Nonproprietary name
Insect Bite Relief
Dosage form
LIQUID
Route
TOPICAL
Labeler
Wisconsin Pharmacal Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-15
Substance
PHENOL; CAMPHOR (SYNTHETIC); BENZOCAINE
Active strength
.21; .46; .77 g/14.7mL; g/14.7mL; g/14.7mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
BiteMD
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOL.21 g/14.7mL
CAMPHOR (SYNTHETIC).46 g/14.7mL
BENZOCAINE.77 g/14.7mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
339NCG44TVInternal UNII lookup
5TJD82A1ETInternal UNII lookup
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1435257Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f860c1e-a638-4923-e063-6294a90ae7e2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68093-9561-1BiteMD14.7 mL in 1 VIAL, PLASTICLIQUID14.71
68093-9561-2BiteMD1 in 1 BLISTER PACKLIQUID11

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 9 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE BACK PAIN THERAPYCAMPHOR 80MG MENTHOL 24MG BACK PAIN THERAPYJiangxi Yudexi Pharmaceutical Co., LTD4dfc77bb-11dd-e0f0-e063-6294a90a4e9c2026-07-24WarningsExact identifier
application number: M017
DRAVYNOR QUIT SMOKING PatchesNICOTINE18% MENTHOL 0.3% QUIT SMOKING PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5768631f-d517-5b43-e063-6294a90a8f462026-07-24WarningsExact identifier
application number: M017
DERMFREE NUMBINGLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a5b47ce-2bf1-42c7-e063-6294a90af09f2026-07-23WarningsExact identifier
application number: M017
DERMFREE WART CORN REMOVERSALICYLIC ACID 40% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c63b3-44de-8736-e063-6394a90ac21a2026-07-23WarningsExact identifier
application number: M017
DERMFREE Anti-itchHYDROCORTISONE1% ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a5af4c6-555a-e74c-e063-6394a90aa6ce2026-07-23WarningsExact identifier
application number: M017
DERMFREE HEMORRHOIDLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4a5d0e79-d620-0147-e063-6294a90a31032026-07-23WarningsExact identifier
application number: M017
MAG 5 PT WARMING FORMULAMENTHOLRENU LABORATORIES, LLCa499ac9b-0e8e-e23f-e053-2a95a90abe9a2026-07-23WarningsExact identifier
application number: M017
Icy Hot Performance Cream Pain ReliefMENTHOL 16%, CAMPHOR 11%Chattem, Inc.73f7a113-ef11-4932-bf4d-4e62863f79412026-07-23WarningsExact identifier
application number: M017
Numbing Pain ReliefLIDOCAINE 4%Walgreen Company2425badb-e196-e9f8-e063-6294a90a7bf42026-07-22WarningsExact identifier
application number: M017
Cooling Pain ReliefMENTHOL 4.5%Walgreen Company24345ccf-c96f-31b0-e063-6294a90a82b52026-07-22WarningsExact identifier
application number: M017
Heat Pain ReliefCAPSAICIN 0.1%Walgreen Company2434f9cf-74aa-17af-e063-6294a90a56d92026-07-22WarningsExact identifier
application number: M017
Pain Relief Patch LidocaineLIDOCAINEHyVee41c26a66-3371-2c2c-e063-6294a90aa38b2026-07-22WarningsExact identifier
application number: M017
CVS Ultra Strength MuscleMENTHOL, CAMPHOR, METHYL SALICYLATECVS Pharmacy48bef8bc-6e39-a328-e063-6394a90ae4502026-07-22WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pain RelievingMENTHOL, CAMPHORActive and Innovative573c2d85-9e0b-7955-e063-6394a90aff642026-07-22WarningsExact identifier
application number: M017
DOCTOR INK TOPICAL ANTISEPTIC WITH PAIN RELIEFBENZALKONIUM CHLORIDE, LIDOCAINEEnviro Specialty Chemicals Incf7abe66c-dc2d-4ef7-9b11-5b87157fd3022026-07-21WarningsExact identifier
application number: M017
Bclsks NUMBINGMENTHOL 1% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD49e26770-ddf6-7515-e063-6394a90a4ab32026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
application number: M017
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435257benzocaine 5 % / camphor 3 % / phenol 1.35 % Topical SolutionPSN4f860c1e-a638-4923-e063-6294a90ae7e21
1435257benzocaine 50 MG/ML / camphor 30 MG/ML / phenol 13.5 MG/ML Topical SolutionSCD4f860c1e-a638-4923-e063-6294a90ae7e21
1435257benzocaine 5 % / camphor 3 % / phenol 1.35 % Topical SolutionSY4f860c1e-a638-4923-e063-6294a90ae7e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68093-9561-16809395610114.7 mL in 1 VIAL, PLASTIC14.7 mlHistorical
68093-9561-2680939561021 VIAL, PLASTIC in 1 BLISTER PACK (68093-9561-2) / 14.7 mL in 1 VIAL, PLASTIC (68093-9561-1) 2026-04-15NoNoCurrent