Orajel for Cold Sores Double Medicated, Cream

Product NDC
10237-797
11-digit product format
102370797
Labeler code
10237
Product ID
10237-797_45382973-75d6-bf98-e063-6294a90a50fc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and White Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Church & Dwight Co., Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-18
Substance
BENZOCAINE; PETROLATUM
Active strength
200; 736.4 mg/g; mg/g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [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 for Cold Sores Double Medicated, Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g
PETROLATUM736.4 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8699a40-8464-ca02-e053-2995a90a4260Available 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
10237-797-12Orajel for Cold Sores Double Medicated, Cream3.5 g in 1 TUBECREAM3.55
10237-797-12Orajel for Cold Sores Double Medicated, Cream1 in 1 CARTONCREAM15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-797ORAJEL FOR COLD SORES DOUBLE MEDICATED, CREAM (BENZOCAINE AND WHITE PETROLATUM) CREAM [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 2 package rows20241129_b8699a40-8464-ca02-e053-2995a90a4260.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 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
application number: M017
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
Eagle Brand Eagle BalmCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA0ba74dba-ec98-09d7-e063-6394a90a22db2026-08-27WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a16c6aa-3ab0-3e46-e063-6294a90a6d8f2026-08-27WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
application number: M017
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
application number: M017
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-797-12102370797121 TUBE in 1 CARTON (10237-797-12) / 3.5 g in 1 TUBE1 tube2021-01-180000-00-00NoNoCurrent