FDA.reportPublic FDA data

ANBESOL COLD SORE THERAPY

Product NDC
0573-0246
Requested package NDC
0573-0246-26
11-digit product format
005730246
Labeler code
0573
Product ID
0573-0246_7ace5d51-e912-4a2b-8f40-a861ffc778b4
Type
HUMAN OTC DRUG
Nonproprietary name
allantion, benzocaine, camphor, petrolatum
Dosage form
OINTMENT
Route
TOPICAL
Labeler
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-05-09
Marketing end
0000-00-00
Substance
ALLANTOIN; BENZOCAINE; CAMPHOR (SYNTHETIC); PETROLATUM
Active strength
10 mg/g; mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0573-02460573-0246-26IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0246-252022-01-28C16284748780-1d6a99b39-999d-a426-e053-dadaa90af4c2Drug Facts
0573-0246-262022-01-28C16284748780-1d6a99b39-999d-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0246-25ANBESOL COLD SORE THERAPY1 in 1 BLISTER PACKOINTMENT16
0573-0246-25ANBESOL COLD SORE THERAPY9 g in 1 TUBEOINTMENT96
0573-0246-26ANBESOL COLD SORE THERAPY9 g in 1 TUBEOINTMENT96
0573-0246-26ANBESOL COLD SORE THERAPY1 in 1 BLISTER PACKOINTMENT16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0246-25GM - Gram0573-0246b7119f84-1b88-4cb3-aa5b-59c9b4548ee412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
allantoinACTIVE INGREDIENT344S277G0ZANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
benzocaineACTIVE INGREDIENTU3RSY48JW5ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ETANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
petrolatumACTIVE INGREDIENT4T6H12BN9UANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
allantoinACTIVE MOIETY344S277G0ZANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
benzocaineACTIVE MOIETYU3RSY48JW5ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ETANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
petrolatumACTIVE MOIETY4T6H12BN9UANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
alpha-tocopherolINACTIVE INGREDIENTH4N855PNZ1ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
butylparabenINACTIVE INGREDIENT3QPI1U3FV8ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
mentholINACTIVE INGREDIENTL7T10EIP3AANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3
white waxINACTIVE INGREDIENT7G1J5DA97FANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [PFIZER CONSUMER HEALTHCARE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0246ANBESOL COLD SORE THERAPY (ALLANTION, BENZOCAINE, CAMPHOR, PETROLATUM) OINTMENT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]6Legacy NDC, 4 package rows20201126_25bcfa70-64f9-18d6-51b0-83282c2f84be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006096allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum 64.9 % Topical OintmentPSN25bcfa70-64f9-18d6-51b0-83282c2f84be6
1052620Anbesol Cold Sore Therapy 1 % / 20 % / 3 % / 64.9 % Topical OintmentPSN25bcfa70-64f9-18d6-51b0-83282c2f84be6
1052620allantoin 0.01 MG/MG / benzocaine 0.2 MG/MG / camphor 0.03 MG/MG / petrolatum 0.649 MG/MG Topical Ointment [Anbesol Cold Sore Therapy]SBD25bcfa70-64f9-18d6-51b0-83282c2f84be6
1006096allantoin 0.01 MG/MG / benzocaine 0.2 MG/MG / camphor 0.03 MG/MG / petrolatum 0.649 MG/MG Topical OintmentSCD25bcfa70-64f9-18d6-51b0-83282c2f84be6
1006096allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum, white 64.9 % Topical OintmentSY25bcfa70-64f9-18d6-51b0-83282c2f84be6
1052620Anbesol Cold Sore Therapy (allantoin 1 % / benzocaine 20 % / camphor 3 % / petrolatum, white 64.9 % ) Topical OintmentSY25bcfa70-64f9-18d6-51b0-83282c2f84be6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0573-0246-26005730246261 TUBE in 1 BLISTER PACK (0573-0246-26) > 9 g in 1 TUBE1 tube2008-09-150000-00-00NoNoCurrent