FDA.reportPublic FDA data

Orajel Cold Sore Moisturelock

Product NDC
10237-761
11-digit product format
102370761
Labeler code
10237
Product ID
10237-761_27d37e6f-4fd8-ce0e-e063-6394a90ad259
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-07-01
Substance
BENZOCAINE; ALLANTOIN; CAMPHOR (NATURAL); DIMETHICONE; MENTHOL; PETROLATUM
Active strength
200; 5; 30; 20; 10; 640 mg/g; mg/g; mg/g; mg/g; mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Skin Barrier Activity [PE], Standardized Chemical Allergen [EPC]
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
Orajel Cold Sore Moisturelock
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
ALLANTOIN5 mg/g
CAMPHOR (NATURAL)30 mg/g
DIMETHICONE20 mg/g
MENTHOL10 mg/g
PETROLATUM640 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
344S277G0ZInternal UNII lookup
N20HL7Q941Internal UNII lookup
92RU3N3Y1OInternal UNII lookup
L7T10EIP3AInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2257305Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3761c7b3-053b-0f50-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-761-01Orajel Cold Sore Moisturelock3 g in 1 TUBECREAM38
10237-761-01Orajel Cold Sore Moisturelock1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-761ORAJEL COLD SORE MOISTURELOCK (BENZOCAINE) CREAM [CHURCH & DWIGHT CO., INC.]8Current NDC, Legacy NDC, 2 package rows20241127_3761c7b3-053b-0f50-e054-00144ff88e88.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 2 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petroleum Skin ProtectantWHITE PETROLATUMYour Military Exchanges1a0aed14-8606-4676-b4b5-23dd415d43ac2026-09-02Warnings, Adverse reactionsExact identifier
application number: M016
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED5a57b197-3e18-b3ab-e063-6394a90aed822026-08-31WarningsExact identifier
application number: M016
HYDROPHORHYDROPHORAkron Pharma Inc.e6099df7-d418-479a-9d2e-ced523585aed2026-08-28WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELUnited Natural Foods, Inc. dba UNFId2d1bd9e-7025-4151-95f2-a2f521dc2be82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDIMETHICONEYour Military Exchangese7af5488-1c49-41e9-9d8b-d519c61076992026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-08-27WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d964138-f68d-dbf5-e063-6294a90a83202026-08-27WarningsExact identifier
application number: M016
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
application number: M016
Serawise Eczema ReliefOATMEALDrAnaMaria. Com LLCf0681436-d140-4e02-afe4-5b16de07afcd2026-08-26WarningsExact identifier
application number: M016
Hair Regrowth FoamGLYCERINShantou Ouhoe Technology Co., Ltd.59ef5953-e96f-5707-e063-6294a90a30942026-08-26WarningsExact identifier
application number: M016
Growth TreatmentGLYCERINShantou Ouhoe Technology Co., Ltd.59fe12eb-574f-a199-e063-6394a90abd062026-08-26WarningsExact identifier
application number: M016
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELYour Military Exchanges4079fd56-55f3-4e69-93e0-7590c07fb7942026-08-25Warnings, Adverse reactionsExact identifier
application number: M016
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
application number: M016
ClaravieDIMETHICONEGentell LLC59c6da39-b5f1-8253-e063-6394a90a0e8f2026-08-24WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP0d94fd18-a120-e171-e063-6394a90ae9c02026-08-24WarningsExact identifier
application number: M016
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
application number: M016
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2257305allantoin 0.5 % / benzocaine 20 % / camphor 3 % / dimethicone 2 % / menthol 1 % / petrolatum 64 % Topical CreamPSN3761c7b3-053b-0f50-e054-00144ff88e888
2257305allantoin 5 MG/ML / benzocaine 200 MG/ML / camphor 30 MG/ML / dimethicone 20 MG/ML / menthol 10 MG/ML / petrolatum 640 MG/ML Topical CreamSCD3761c7b3-053b-0f50-e054-00144ff88e888
2257305allantoin 0.5 % / benzocaine 20 % / camphor 3 % / dimethicone 2 % / menthol 1 % / petrolatum 64 % Topical CreamSY3761c7b3-053b-0f50-e054-00144ff88e888

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-761-01102370761011 TUBE in 1 CARTON (10237-761-01) / 3 g in 1 TUBE1 tube2016-07-010000-00-00NoNoCurrent