FDA.reportPublic FDA data

Topical Edge

Manufacturer
AmperSand Biopharma
Effective date
2017-08-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:33

Label at a glance#

ProductTopical Edge
Active ingredientMENTHOL
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Edge LabelTopical Edge Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293193menthol 0.5 % Topical LotionPSN1
1293193menthol 5 MG/ML Topical LotionSCD1
1293193menthol 0.5 % Topical LotionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70458-500-022020-01-31C16284748780-19d75b9d0-b8ff-f424-e053-dadaa90a57ce5815d5b2-5fbf-780a-e053-2a91aa0ae946

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70458-500-02Topical Edge300 g in 1 TUBELOTION3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70458-500TOPICAL EDGE (MENTHOL) LOTION [AMPERSAND BIOPHARMA]1Legacy NDC, 1 package rows20170925_5815d5b2-5fbf-780a-e053-2a91aa0ae946.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70458-50070458-500-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
JOJOBA OIL724GKU717MIACT
SORBIC ACIDX045WJ989BIACT
POLYGLYCERYL-4 OLEATE15B05TY4GXIACT
POLYGLYCERYL-4 STEARATEVLC3W3U1PEIACT
WATER059QF0KO0RIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
COCONUT OILQ9L0O73W7LIACT
PALM KERNEL OILB0S90M0233IACT
SODIUM BICARBONATE8MDF5V39QOIACT
ALCOHOL3K9958V90MIACT
BENZYL ALCOHOLLKG8494WBHIACT
HYDRATED SILICAY6O7T4G8P9IACT
MENTHOLL7T10EIP3AACTIB
LECITHIN, SOYBEAN1DI56QDM62IACT
POLOXAMER 407TUF2IVW3M2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

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
5815d5b2-5fc0-780a-e053-2a91aa0ae9465815d5b2-5fbf-780a-e053-2a91aa0ae9462017-08-31Exact identifier
spl id: 5815d5b2-5fc0-780a-e053-2a91aa0ae946
spl set id: 5815d5b2-5fbf-780a-e053-2a91aa0ae946

Reported adverse events (FAERS/openFDA)#

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