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 86 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ULTRA STRENGTH ZHENG GU SHUIMENTHOL AND CAMPHORGUANGXI YULIN PHARMACEUTICAL GROUP CO LTD53397663-044d-4e48-989b-2c6257af5f842025-07-14Warnings, Adverse reactionsExact identifier
application number: M017
TIGER BALM PAIN RELIEVING HYDROGELCAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.cb60037f-bceb-4090-a5e4-bdda0cbf9f5c2025-07-14WarningsExact identifier
application number: M017
Avedana Hydrocortisone Cream with AloeHYDROCORTISONEUnipack LLC2a55c426-39b4-4d94-b6b4-6c548c9685e92025-07-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATERite Aid Corporationcb6e0bed-2ea1-49d2-89e7-2554e7565b742025-07-11WarningsExact identifier
application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll OnLIDOCAINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c42025-07-11WarningsExact identifier
application number: M017
Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETARGET Corporation6fba5890-f48f-4302-a8ac-5087a6e03bd52025-07-11WarningsExact identifier
application number: M017
TopCare Antibiotic Plus Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDETopco Associates LLC55dc4025-f07f-41b2-8b18-6a11ee04b5cc2025-07-11WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLC309d9be0-e367-429a-a1fa-ab7855477c8a2025-07-10WarningsExact identifier
application number: M017
Bengay Vanishing ScentMENTHOL, UNSPECIFIED FORMKenvue Brands LLC6cc3294b-3b0f-44d0-af71-61db1022d2692025-07-10WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLQuality Choicece544a7c-8dc6-4e63-b499-d8a4e0ec48c32025-07-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE ACETATEWalgreen Companybff322f1-59c3-41e0-8685-fcfe52bf4b422025-07-10WarningsExact identifier
application number: M017
CVS CortisoneHYDROCORTISONECVS Pharmacy87631be8-94b8-4718-858d-d2f30e636cce2025-07-10WarningsExact identifier
application number: M017
TopCare Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETopco Associates LLCc40e8e1d-d6d7-4880-99d3-011b97a5e4f32025-07-10WarningsExact identifier
application number: M017
Live Better Hydrocortisone with AloeHYDROCORTISONEThe Great Atlantic & Pacific Tea Company044e6ee2-98a6-4802-b33d-78b8551356c42025-07-10WarningsExact identifier
application number: M017
Rocainol TOPICAL ANALGESICMETHYL SALICYLATE, MENTHOLCompania Internacional de Comercio, S.A.P.I de C.V.827ec7b2-3d87-47e0-a47a-966b25732c322025-07-10WarningsExact identifier
application number: M017
NumbR-XLIDOCAINE HCLProdigy Media Inc16329ab6-4a33-4c38-85e0-5aad9c75d61d2025-07-10WarningsExact identifier
application number: M017
Dr LidoLIDOCAINE HCLProdigy Media Incda0938f0-00e7-4502-8721-d64c71f594fc2025-07-10WarningsExact identifier
application number: M017
Pain Relief PatchCAMPHOR, METHYL SALICYLATE, MENTHOLCDMA, Inc.da1ec2fe-cc37-4126-90a8-6eb4b8f2e57b2025-07-09WarningsExact identifier
application number: M017
ORTHOGEL Menthol 3.5%MENTHOLLiquidCapsule Manufacturing LLC4fd4b7ac-1971-4abe-8fbb-74ab69e120612025-07-09WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEAmerisourceBergenf36acdb8-a526-4bb7-a557-e1dcbbc1cf452025-07-08WarningsExact 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