FDA.reportPublic FDA data

Campho-Phenique

Product NDC
69536-108
11-digit product format
695360108
Labeler code
69536
Product ID
69536-108_284cb346-f76b-53af-e063-6394a90a2aa4
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR (SYNTHETIC) and PHENOL
Dosage form
GEL
Route
TOPICAL
Labeler
Foundation Consumer Healthcare LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-01
Substance
CAMPHOR (SYNTHETIC); PHENOL
Active strength
10.8; 4.7 g/100g; g/100g
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
Cold Sore Treatment
Listing expiration
2026-12-31

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
106c0bb2-f2e2-4255-867d-d09ff6a5a2e6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69536-108-23Campho-PheniqueCold Sore Treatment1 in 1 CARTONGEL14
69536-108-23Campho-PheniqueCold Sore Treatment6.5 g in 1 TUBEGEL6.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69536-108-23GM - Gram69536-108b40c8512-2d68-44e7-ac9a-7b8c3944fec412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69536-108CAMPHO-PHENIQUE COLD SORE TREATMENT (CAMPHOR (SYNTHETIC) AND PHENOL) GEL [FOUNDATION CONSUMER HEALTHCARE LLC]4Current NDC, Legacy NDC, 2 package rows20241204_106c0bb2-f2e2-4255-867d-d09ff6a5a2e6.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 84 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mountain Ice Sports Pain ReliefMENTHOL, CAMPHORMountainside Medical Equipment, Inc.c1f5512c-67b1-4ff0-b1a5-616e883d436f2025-07-21WarningsExact identifier
application number: M017
Stopain Clinical Roll-OnMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.27703209-fdac-4620-a445-d89a84bc853d2025-07-21WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC9bac1869-8072-49bd-8568-a87a184d22002025-07-21WarningsExact identifier
application number: M017
Dr Kevin Khalili Pain Relief CreamMENTHOLDR. KHALILI LLC3a79b38c-9adc-60dd-e063-6394a90a5b302025-07-21WarningsExact identifier
application number: M017
ARTHRITIS PAIN RELIEFCAMPHOR, CAPSAICIN, METHYL SALICYLATEYUNNAN BAIYAO GROUP CO., LTD.671c57f0-3c6f-4416-bc81-f6930fef327b2025-07-21WarningsExact identifier
application number: M017
GoodSense Cooling Pain ReliefMENTHOLGeiss, Destin & Dunn, Inc2e5e1375-df07-9a43-e063-6394a90a99382025-07-20WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch CoolingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa7eae5dc-9db6-4bdf-9179-76060e75e0442025-07-18WarningsExact identifier
application number: M017
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
application number: M017
Aouiv 4% Lidocaine Numbing Cream4% LIDOCAINE NUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.3a221dd2-e945-bd0e-e063-6294a90a8fb92025-07-17WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.24538037-1d74-48a0-b909-98ecc57651fe2025-07-17WarningsExact identifier
application number: M017
Hydrocortisone anti-itch plusHYDROCORTISONEWal-Mart Stores, Inc.a0c6e180-b385-4a9b-a9cf-84a551f533d02025-07-16WarningsExact identifier
application number: M017
OTC Rescue Lidocaine Pain Relief PatchLIDOCAINEVeridian Healthcare0e742fc6-5f76-d202-e063-6394a90acf312025-07-16WarningsExact identifier
application number: M017
Itch ReliefHYDROCORTISONESTRATEGIC SOURCING SERVICES LLCae4b7cd6-8b5d-4d25-86f9-72260638bb942025-07-16WarningsExact identifier
application number: M017
Freds Hydrocortisone Plus 12 MoisturizersHYDROCORTISONEFRED'S, INC.7502eebe-11c5-4e9e-b427-b87180a843492025-07-16WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.39688b2b-c1fe-cd86-e063-6394a90a53452025-07-16WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
application number: M017
TopCare Hydrocortisone Intensive Healing FormulaHYDROCORTISONETopco Associates LLC7daafc44-e2a4-4f1b-bfca-3309a8e9a9202025-07-15WarningsExact identifier
application number: M017
Hydrocortisone Plus 12 MoisturizersHYDROCORTISONETARGET Corporation72c3889c-b743-4728-a315-6e4063e002002025-07-15WarningsExact identifier
application number: M017
Shopko Hydrocortisone Maximum StrengthHYDROCORTISONEShopko Stores Operating Co., LLC0431a6af-4c9a-4bbd-a535-cba31a5e53cc2025-07-15WarningsExact identifier
application number: M017
Freds Hydrocortisone with AloeHYDROCORTISONEFRED'S, INC.076503bf-8238-4739-bb1c-c385e72f8a962025-07-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
210347Campho-Phenique 10.8 % / 4.7 % Topical GelPSN106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 10.8 % / phenol 4.7 % Topical GelPSN106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
210347camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]SBD106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical GelSCD106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
210347Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 0.11 MG/MG / phenol 0.05 MG/MG Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64
308939camphor 10.8 % / phenol 4.7 % Topical GelSY106c0bb2-f2e2-4255-867d-d09ff6a5a2e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69536-108-23695360108231 TUBE in 1 CARTON (69536-108-23) / 6.5 g in 1 TUBE1 tube2017-08-010000-00-00NoNoCurrent