FDA.reportPublic FDA data

Campho-Phenique

Product NDC
69536-110
11-digit product format
695360110
Labeler code
69536
Product ID
69536-110_284f74b6-532e-3ad8-e063-6394a90aae6b
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC) and PHENOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Foundation Consumer Healthcare LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-06-01
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 mg/100mL; mg/100mL
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
Campho-Phenique
Brand name suffix
Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)10.8 mg/100mL
PHENOL4.7 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
210346Internal RxNorm lookup
308940Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
82edaef0-0709-4ae1-a664-c9c5adb91ee1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-110-75Campho-PheniqueAntiseptic22 mL in 1 BOTTLELIQUID224
69536-110-75Campho-PheniqueAntiseptic1 in 1 CARTONLIQUID14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-110-75ML - Milliliter69536-1105045bc44-6efd-4074-a413-7e8d9658ecab12018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-110CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) LIQUID [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 2 package rows20241204_82edaef0-0709-4ae1-a664-c9c5adb91ee1.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 92 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
application number: M017
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company3508ae14-d9c9-3c85-e063-6294a90a00982025-05-13WarningsExact identifier
application number: M017
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
application number: M017
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
application number: M017
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
application number: M017
Mqupin Knee PatchKNEE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09772e4b-8193-3771-e063-6394a90a95162025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USAd57a59fb-c8f2-f73b-e053-2995a90a4cdb2025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
application number: M017
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
application number: M017
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
application number: M017
DermaRad Relief Post Radiation CalmingLIDOCAINE 3 PERCENTRenu Laboratories, LLCe5d64929-fb9c-7ebc-e053-2995a90a93182025-05-07WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210346Campho-Phenique 10.8 % / 4.7 % Topical SolutionPSN82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 10.8 % / phenol 4.7 % Topical SolutionPSN82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346camphor 108 MG/ML / phenol 47 MG/ML Topical Solution [Campho-Phenique]SBD82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 108 MG/ML / phenol 47 MG/ML Topical SolutionSCD82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14
210346Campho-Phenique (camphor 108 MG/ML / phenol 47 MG/ML) Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14
308940camphor 10.8 % / phenol 4.7 % Topical SolutionSY82edaef0-0709-4ae1-a664-c9c5adb91ee14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-110-75695360110751 BOTTLE in 1 CARTON (69536-110-75) / 22 mL in 1 BOTTLE1 bottle2021-11-150000-00-00NoNoCurrent