FDA.reportPublic FDA data

Campho-Phenique

Product NDC
69536-109
11-digit product format
695360109
Labeler code
69536
Product ID
69536-109_47f72480-dce3-904c-e063-6294a90a67d6
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor (synthetic) and Phenol
Dosage form
GEL
Route
TOPICAL
Labeler
Foundation Consumer Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-15
Marketing end
2027-04-30
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 g/100g; g/100g
NDC exclude flag
No
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

Active Ingredients#

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

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
210347Internal RxNorm lookup
308939Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
46b84e0b-78a9-4cde-9f90-e165b5419162Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-109-50Campho-PheniqueAntiseptic14 g in 1 TUBEGEL145
69536-109-50Campho-PheniqueAntiseptic1 in 1 CARTONGEL15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-109-50GM - Gram69536-1099f98ac0b-df65-4c7b-b67e-d3e105c70b2612018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-109CAMPHO-PHENIQUE ANTISEPTIC (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE]4Current NDC, Legacy NDC, 2 package rows20241204_46b84e0b-78a9-4cde-9f90-e165b5419162.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 56 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LidoGuardLIDOCAINE HCLALAINA HEALTHCARE PRIVATE LIMITEDc339dffe-bc9b-4fae-a50f-8db463d244c12025-12-09WarningsExact identifier
application number: M017
Capsaicin Cream 0.075%CAPSAICINALAINA HEALTHCARE PRIVATE LIMITED33e861bd-bb92-4aea-9d4d-1b8847c794fd2025-12-09WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEALAINA HEALTHCARE PRIVATE LIMITEDe07c5ebc-5497-4c45-acc5-d12e72e98f3f2025-12-09WarningsExact identifier
application number: M017
Ultra Strength Pain Relief BalmCAMPHOR, MENTHOLALAINA HEALTHCARE PRIVATE LIMITED80779d1f-0c2a-4ae5-9ed7-eb6877f734ba2025-12-09WarningsExact identifier
application number: M017
Pain Relief BalmMENTHOL AND CAMPHORALAINA HEALTHCARE PRIVATE LIMITED12d76b8f-4b1d-4f2d-9722-0adb55093cc42025-12-09WarningsExact identifier
application number: M017
Trojan Extended PleasureBENZOCAINEChurch & Dwight Co., Inc.be731682-4174-649a-e053-2a95a90a39872025-12-09WarningsExact identifier
application number: M017
Stopain Clinical ContinuousMENTHOLTroy Manufacturing, Inc.65f8d212-0f0e-4893-b6af-bd68bba464432025-12-09WarningsExact identifier
application number: M017
Pain and Itch Relief 4% LidocaineLIDOCAINEWalgreensf84e76a9-6af6-4fd1-be4e-efa05728cbfd2025-12-09WarningsExact identifier
application number: M017
CapsimideCAPSAICIN 0.025% TOPICAL PATCHSola Pharmaceuticalse81c2de8-6429-d681-e053-2995a90a36a92025-12-08WarningsExact identifier
application number: M017
Extra Strength Cold-Hot Medicated PatchesMENTHOLCardinal Health, 110 dba LEADERa2895c03-747c-4220-8052-4f04280626222025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER5feae39e-3ab8-4cda-b9e8-dc221aea24172025-12-08WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATECardinal Health, 110 dba LEADERf8837b69-8d85-448c-a4b4-be911bca1f6c2025-12-08WarningsExact identifier
application number: M017
CAPSAICIN HOT PATCHESCAPSAICINCardinal Health, 110 dba LEADER76e6bc39-643c-4264-8d98-0e4fa7d778e22025-12-08WarningsExact identifier
application number: M017
Leader PAIN RELIEF PATCHESLIDOCAINECardinal Health, 110 dba LEADER3be6defd-f429-4dc7-8b37-5910705c0b812025-12-08WarningsExact identifier
application number: M017
LenzaPro FlexLIDOCAINE/MENTHOLSOLA Pharmaceuticalsba498f1d-460b-f4e6-e053-2995a90a57552025-12-08WarningsExact identifier
application number: M017
LidaFlexLIDOCAINESOLA Pharmaceuticalsb9e49529-13b4-1b0b-e053-2995a90adc7a2025-12-08WarningsExact identifier
application number: M017
Rugby Menthol Hot Cold PatchMENTHOLRUGBY LABORATORIESc68d29c2-9b56-4994-e053-2a95a90ae60e2025-12-08WarningsExact identifier
application number: M017
Neuracin Topical GelNEURACIN TOPICAL ANALGESIC GELSOLA Pharmaceuticalsc3166926-30c2-2128-e053-2a95a90a0bf22025-12-08WarningsExact identifier
application number: M017
TriceptinLIDOCAINE / MENTHOL / METHYL SALICYLATESOLA Pharmaceuticalsef1b98ab-d2db-038c-e053-2995a90a94b42025-12-08WarningsExact identifier
application number: M017
SynoFlex PatchSYNOFLEX PATCHSola Pharmaceuticalsde2042c4-6c5e-7365-e053-2a95a90ada2a2025-12-08WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210347Campho-Phenique 10.8 % / 4.7 % Topical GelPSN46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 10.8 % / phenol 4.7 % Topical GelPSN46b84e0b-78a9-4cde-9f90-e165b54191625
210347camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]SBD46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical GelSCD46b84e0b-78a9-4cde-9f90-e165b54191625
210347Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 0.11 MG/MG / phenol 0.05 MG/MG Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625
308939camphor 10.8 % / phenol 4.7 % Topical GelSY46b84e0b-78a9-4cde-9f90-e165b54191625

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-109-50695360109501 TUBE in 1 CARTON (69536-109-50) / 14 g in 1 TUBE1 tube2021-11-152027-04-30NoNoCurrent