FDA.reportPublic FDA data

SC HERBAL

Product NDC
82198-0015
11-digit product format
821980015
Labeler code
82198
Product ID
82198-0015_0b32bdc5-c8ed-e6cb-e063-6394a90aa155
Type
HUMAN OTC DRUG
Nonproprietary name
methyl salicylate, menthol, camphor
Dosage form
PATCH
Route
TOPICAL
Labeler
Big 5 Nutrition LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.031; .06; .1 g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SC HERBAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.031 g/g
METHYL SALICYLATE.06 g/g
CAMPHOR (SYNTHETIC).1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal UNII lookup
5TJD82A1ETInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1793147Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b79b6f57-d062-4c6d-ade8-dfa841c6bf0fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82198-0015-1SC HERBAL5.9 g in 1 PATCHPATCH5.91
82198-0015-1SC HERBAL3 in 1 BAGPATCH31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82198-0015SC HERBAL (METHYL SALICYLATE, MENTHOL, CAMPHOR) PATCH [BIG 5 NUTRITION LLC]1Current NDC, 2 package rows20240101_b79b6f57-d062-4c6d-ade8-dfa841c6bf0f.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SC HERBALMETHYL SALICYLATE, MENTHOL, CAMPHORBig 5 Nutrition LLCb79b6f57-d062-4c6d-ade8-dfa841c6bf0f2023-11-28WarningsExact identifier
ndc (product): 82198-0015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSNb79b6f57-d062-4c6d-ade8-dfa841c6bf0f1
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDb79b6f57-d062-4c6d-ade8-dfa841c6bf0f1
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSYb79b6f57-d062-4c6d-ade8-dfa841c6bf0f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82198-0015-1821980015013 PATCH in 1 BAG (82198-0015-1) / 5.9 g in 1 PATCH3 patch2024-01-01NoNoCurrent