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 140 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Valtrum IMMEDIATE ACTION TOPICAL ANALGESICCAMPHOR, MENTHOL, METHYL SALICYLATELABORATORIOS QUANTIUM LLCc4efa317-8dd1-49e1-b7ca-9df2147edd3e2023-12-21WarningsExact identifier
application number: M017
DDM Camphor SpiritCAMPHOR 10%Discount Drug Mart5d56cbe6-4e48-79eb-e053-2a91aa0a74d32023-12-20WarningsExact identifier
application number: M017
Quality Choice Camphor SpiritCAMPHOR 10%Chain Drug Market Association8d352a67-2024-43d0-b525-038d398949e62023-12-20WarningsExact identifier
application number: M017
Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Chain Drug Market Association2cd60df3-bfde-4747-ba4f-7121612f2e632023-12-20WarningsExact identifier
application number: M017
Poison Ivy WashPRAMOXINE HCLChain Drug Market Association873a546b-90ae-50cb-e053-2a91aa0adbfb2023-12-20WarningsExact identifier
application number: M017
Premier Value Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Pharmacy Value Alliance LLC9d63f8ed-fc50-0d84-e053-2a95a90a6e922023-12-20WarningsExact identifier
application number: M017
Ear DropsCARBAMIDE PEROXIDE 6.5%CVS Pharmacy8a872991-01af-5fd0-e053-2995a90ac7f42023-12-20WarningsExact identifier
application number: M017
CVS Cold and Hot Roll-OnCOOL AND HEAT PAIN RELIEFCVS Pharmacyb8cc578a-be6d-90c0-e053-2995a90a77422023-12-20WarningsExact identifier
application number: M017
Sunmark Camphor SpiritCAMPHOR 10%Strategic Sourcing Services LLC667b3a9f-4a5c-4ef0-adbd-cce9a5f94faa2023-12-19WarningsExact identifier
application number: M017
DDM Instant Antiseptic Pain ReliefCAMPHOR 10.8% AND PHENOL 4.7%Discount Drug Mart5d56c74f-604d-4fed-e053-2a91aa0a417c2023-12-19WarningsExact identifier
application number: M017
HEB Camphor PhenolCAMPHOR 10.8% AND PHENOL 4.7%H E B5d573883-001d-e5a4-e053-2991aa0a62032023-12-18WarningsExact identifier
application number: M017
Petrocort Antipruritic Lip 21HYDROCORTISONEClinical Formula LLC7d408e08-d777-4dfb-bb5e-b4fe5d6f4c7b2023-12-15WarningsExact identifier
application number: M017
DermaWound Wound Care Venous StasisBENZOCAINE HYDROCHLORIDEProgressive Doctors, LLC6221ba86-8b7f-48c8-8284-6950f9fc36b12023-12-15WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll-OnLIDOCAINE 4%Humco Holding Group, Inc.a8be9e46-1616-40a9-e053-2a95a90ac3bc2023-12-15WarningsExact identifier
application number: M017
Hot/Cold Menthol 16% Roll-OnHOT/COLD MENTHOL 16% ROLL-ONHumco Holding Group, Inca8bf9744-9979-13c1-e053-2a95a90a30aa2023-12-15WarningsExact identifier
application number: M017
Freds Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLDiscount Drug Mart8697b932-da5a-717e-e053-2a91aa0afcae2023-12-12WarningsExact identifier
application number: M017
CVS Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLCVS86972218-31fe-6942-e053-2991aa0a88502023-12-12WarningsExact identifier
application number: M017
Best Choice Medicated anti itchPRAMOXINE HYDROCHLORIDE, MENTHOLvalue merchandisers869631f8-aa1e-8ea4-e053-2a91aa0a5c572023-12-12WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Weeks & Leo Co., Inc.0c5325e3-4796-856c-e063-6394a90a1f902023-12-12WarningsExact identifier
application number: M017
Westlake Anti-itchHYDROCORTISONEWestlake Pharma LLC0c53c982-3f23-a2d5-e063-6394a90acd552023-12-12WarningsExact 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