HERSTAT PLUS Cold Sore Treatment

Product NDC
90100-221
11-digit product format
901000221
Labeler code
90100
Product ID
90100-221_2995ae00-d286-0fea-e063-6294a90a2c4b
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Herstat (USA) Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-06-22
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
3; .1 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
HERSTAT PLUS Cold Sore Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3 g/100g
MENTHOL.1 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
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2604563Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e20ea714-663d-c4ac-e053-2a95a90a5eccAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
90100-221-022024-01-30C16284748780-11030e365-4bc9-111a-e063-dadaa90a10e2HERSTAT PLUS Cold Sore Treatment Moisturizing Lip Care Stick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
90100-221-02HERSTAT PLUS Cold Sore Treatment2 g in 1 TUBEOINTMENT25
90100-221-02HERSTAT PLUS Cold Sore Treatment1 in 1 CARTONOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
90100-221HERSTAT PLUS COLD SORE TREATMENT (CAMPHOR, MENTHOL) OINTMENT [HERSTAT (USA) INC.]5Current NDC, Legacy NDC, 2 package rows20250406_e20ea714-663d-c4ac-e053-2a95a90a5ecc.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 119 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017
LidocaineLIDOCAINEPatrin Pharma Inc.91eedf9d-53b8-49d5-af59-25019606a0b22024-11-15WarningsExact identifier
application number: M017
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFId1ac686e-62f2-4177-8abc-8c7ca578de1a2024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving Max Strength with Lavender Essential Oil AnalgesicLIDOCAINE HYDROCHLORIDEMeijer Distribution, Ince688967e-799a-4fc8-a19a-f0012b90e76b2024-11-15WarningsExact identifier
application number: M017
basic care hydrocortisoneHYDROCORTISONEAmazon.com Services LLCa0d0e82b-03ff-4d43-9be0-0e414ee499702024-11-15WarningsExact identifier
application number: M017
DG health hydrocortisoneHYDROCORTISONEDolgencorp, LLC40710bae-32bb-47fd-b3dd-31d2c98ee70f2024-11-15WarningsExact identifier
application number: M017
Meijer Ultra Strength Pain Relieving Topical AnalgesicCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEMeijer Distribution, Inc6319b019-8e17-4de1-b4e0-b402288a97d42024-11-15WarningsExact identifier
application number: M017
Meijer Pain Relieving analgesicCAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc9953be94-5768-448f-83de-f5e53a2972cc2024-11-15WarningsExact identifier
application number: M017
careone anti itchHYDROCORTISONEAmerican Sales Company5f7b1435-ebee-4093-847a-79e8d66414042024-11-15WarningsExact identifier
application number: M017
Tiger BalmMETHYL SALICYLATE AND MENTHOLHaw Par Healthcare Ltd.51293a06-5922-4072-ae14-afaba9c1b58e2024-11-14WarningsExact identifier
application number: M017
Tylenol Precise Warming Pain RelievingLIDOCAINEKenvue Brands LLC0c60b607-ade9-68f2-e063-6394a90a40252024-11-13WarningsExact identifier
application number: M017
Tylenol Precise Pain RelievingLIDOCAINEKenvue Brands LLCfc1e0451-8c84-729e-e053-6394a90aaba02024-11-13WarningsExact identifier
application number: M017
Neosporin Plus Pain Relief First Aid Antibiotic/Pain RelievingNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC23222e54-d793-4d79-980e-550e32a957422024-11-13WarningsExact identifier
application number: M017
TopCare Pain Relieving Roll-On Topical AnalgesicMENTHOL, UNSPECIFIED FORMTopco Associates LLC48589893-ca67-471d-88bc-92014295ab9f2024-11-13WarningsExact identifier
application number: M017
Benadryl Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEKenvue Brands LLCa1c1b878-d58f-41ff-b7a8-477f28c526672024-11-12WarningsExact identifier
application number: M017
Real Time Pain Relief Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2604563camphor 3 % / menthol 0.1 % Topical OintmentPSNe20ea714-663d-c4ac-e053-2a95a90a5ecc5
2604563camphor 0.03 MG/MG / menthol 0.001 MG/MG Topical OintmentSCDe20ea714-663d-c4ac-e053-2a95a90a5ecc5
2604563camphor 3 % / menthol 0.1 % Topical OintmentSYe20ea714-663d-c4ac-e053-2a95a90a5ecc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
90100-221-02901000221021 TUBE in 1 CARTON (90100-221-02) / 2 g in 1 TUBE1 tube2022-06-220000-00-00NoNoCurrent