FDA.reportPublic FDA data

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 142 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tact Cool JellyDIPHENHYDRAMINE HYDROCHLORIDE, LEVOMENTHOLSato Pharmaceutical Co., Ltd.f34872c9-91b9-49db-8e41-5b54a069284a2023-12-01WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.348fde05-2797-4410-a1b2-99e64187c4fe2023-12-01WarningsExact identifier
application number: M017
Menthozen HydrogelMENTHOL, CAPSAICINProficient Rx LP85a7809e-c43f-4138-a85b-44e1b586def52023-12-01WarningsExact identifier
application number: M017
Menthozen CreamMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP66681906-c5f5-4c57-bb43-9c83cccc00622023-12-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLProficient Rx LPc0df4b8b-2679-4652-9144-a8db916a186b2023-12-01WarningsExact identifier
application number: M017
Lidozen GelLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP7c300dec-cefd-4b79-a948-a917b7708a042023-12-01WarningsExact identifier
application number: M017
MenthozenMETHYL SALICYLATE, MENTHOL, CAPSAICINProficient Rx LP2adf3c4d-636f-4e02-b501-946b4df5f5d62023-12-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE, MENTHOLProficient Rx LP488d665c-a4fe-4a69-bab3-34b2347f4b052023-12-01WarningsExact identifier
application number: M017
Thera Plus Max Strength Lidocaine Pain Relief LiquidLIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.0a228b06-0e1c-6c75-e063-6294a90a9a0e2023-11-30WarningsExact identifier
application number: M017
Thera Plus Cool and Heat Pain Relieving Gel MentholMENTHOLFourstar Group USA, Inc.0a225714-ccb1-4676-e063-6294a90aeeb22023-11-30WarningsExact identifier
application number: M017
Bloop Itch Soothing TopicalHYDROCORTISONEThree Nations Corp0b64677e-d4bf-0929-e063-6294a90af1372023-11-30WarningsExact identifier
application number: M017
Ice QuakeMENTHOLSouthern Sales & Service, Inc.7a05832f-49ac-4013-b240-4405501e45cd2023-11-29WarningsExact identifier
application number: M017
ICE MUSCLE RUB Leon M.CMENTHOLSouthern Sales & Service, Inc.4efaf347-7406-4690-8005-e7cf2e3d42222023-11-29WarningsExact identifier
application number: M017
IceQuake Analgestic WhiteMETHYL SALICYLATE, MENTHOLSouthern Sales & Service, Inc.54e5dcd5-9987-488d-a758-d0e76d1551822023-11-29WarningsExact identifier
application number: M017
Icequake Coldn Hot medicated patchMENTHOLSouthern Sales & Service, Inc.89202c52-9eb7-4e5a-a709-4a66ab0d3a722023-11-29WarningsExact identifier
application number: M017
IceQuake Lidocaine AnalgesicLIDOCAINE HYDROCHLORIDESouthern Sales & Service, Inc.9089cb78-e9f8-4437-a767-df809a114c4b2023-11-29WarningsExact identifier
application number: M017
Ice Quake Muscle Rub BlueMENTHOLSouthern Sales & Service, Inc.5180f6a3-58f1-4c50-a33b-7d85a3c1b99b2023-11-29WarningsExact identifier
application number: M017
Discount Drug Mart Extra Strength Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEDiscount Drug Mart8579df23-ac07-9df8-e053-2991aa0a8bbb2023-11-29WarningsExact identifier
application number: M017
SatohapMETHYL SALICYLATE, DL-CAMPHOR, L-MENTHOLSato Pharmaceutical Co., Ltd.3a2fc8ae-f1ac-4c64-8e75-d5fdb141aecf2023-11-28WarningsExact identifier
application number: M017
Poli-AHYDROCORTISONE ACETATESato Pharmaceutical Co., Ltd.e27a3840-d9de-4bd0-ad75-8a151bd12b832023-11-28WarningsExact 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