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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLAmazon.com Services LLCadb638ec-4a7c-42f2-b249-0ac53a8dd4b22026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact 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