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 61 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF ROLL-ON 3OZ934d4638-b47b-187d-e053-2995a90ae69d2025-11-20WarningsExact identifier
application number: M017
FOOT PAIN RELIEF ROLL-ONLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd43edcea0-ab04-f368-e063-6294a90a817a2025-11-19WarningsExact identifier
application number: M017
Absolut Skin Corticosoothe Anti-ItchHYDROCORTISONEAbsolut Skin Incorporateddeb52218-9176-4aaa-a22f-b66dada6690f2025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited43f3d189-f6b7-02ed-e063-6394a90afd732025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2ZLIDOCAINEInterMed Laboratories Private Limited43f3e288-e828-8130-e063-6394a90a6d442025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
application number: M017
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
application number: M017
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
application number: M017
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact identifier
application number: M017
Itch EraserDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands2204e135-6a23-68a2-e063-6394a90ac0192025-11-18WarningsExact identifier
application number: M017
Analgesic BalmMENTHOL 10%, METHYL SALICYLATE 15%Geri-Care Pharmaceuticals, Corpc8594e10-661f-6ff3-e053-2995a90ab4fc2025-11-18WarningsExact identifier
application number: M017
Mag 5 PT Cooling Formula Recovery CreamMENTHOLRENU LABORATORIES, LLCa45cde67-64ec-643b-e053-2a95a90a10b62025-11-18WarningsExact identifier
application number: M017
After Ivy WipeCAMPHORTender Corporation d/b/a Adventure Ready Brands21d98018-826a-1d0d-e063-6294a90a0a712025-11-17WarningsExact identifier
application number: M017
Itch Eraser GelDIPHENHYDRAMINE HCLTender Corporation d/b/a Adventure Ready Brands223c7cfd-6dc5-140a-e063-6394a90a83322025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYKroger Co.6b3e7aac-395f-48cf-9c5e-f7e163724aef2025-11-17WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYHY-VEE, INC415ecfe9-3145-f23e-e063-6394a90adfd82025-11-17WarningsExact 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