FDA.reportPublic FDA data

EXTERNAL ANALGESIC

Product NDC
70927-001
11-digit product format
709270001
Labeler code
70927
Product ID
70927-001_0d774b08-e5e4-56c9-e063-6294a90ae8db
Type
HUMAN OTC DRUG
Nonproprietary name
camphor, capsicum, menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Hmong 21
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-08-25
Substance
CAMPHOR (SYNTHETIC); CAPSAICIN; MENTHOL
Active strength
96; .5; 78 mg/g; mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct70927-001EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70927-00170927-001-00EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
EXTERNAL ANALGESIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)96 mg/g
CAPSAICIN.5 mg/g
MENTHOL78 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
S07O44R1ZMInternal 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
1807136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3b6155a5-51aa-2780-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70927-001-00EXTERNAL ANALGESIC4 g in 1 PATCHPATCH45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70927-001EXTERNAL ANALGESIC (CAMPHOR, CAPSICUM, MENTHOL) PATCH [HMONG 21]5Current NDC, Legacy NDC, 1 package rows20231227_3b6155a5-51aa-2780-e054-00144ff8d46c.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 55 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magsoothium BodyMENTHOL, CAPSAICINUbu/Elements, Inc.f604d30c-b17c-ec01-e053-2a95a90aa3042025-12-15WarningsExact identifier
application number: M017
Salonpas pain relieving JETMENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.dd1ea3bf-891a-402e-8f43-14302bc9c3e52025-12-15WarningsExact identifier
application number: M017
Herbal Tendon Bone ReliefCAMPHOR MINTGuchutang Biotechnology (Longyan) Co., Ltd.45cf4040-9751-d24b-e063-6294a90aff272025-12-13WarningsExact identifier
application number: M017
ElixirLidoFastLIDOCAINE 5% CREAMELIXIR HEALTHCARE USA, LLC.45de5a3d-06c2-aa02-e063-6294a90a63d32025-12-13WarningsExact identifier
application number: M017
MEDI FIRST PLUSHYDROCORTISONE ACETATEOrazen Inc5781124a-60f4-4a64-80b7-ce5f28d495b52025-12-12WarningsExact identifier
application number: M017
MEDI-FIRSTHYDROCORTISONE ACETATEOrazen Incaeffd85c-58a7-4d64-bf94-977b6fbbe7132025-12-12WarningsExact identifier
application number: M017
Joint and Muscle ReliefMENTHOLSmart Cookie Solutions Inc.45c24d56-4dc9-2884-e063-6294a90a52cc2025-12-12WarningsExact identifier
application number: M017
PopstarDELAY SPRAYPineapple Brands LLC293b2da9-1261-0358-e063-6394a90aa08c2025-12-12WarningsExact identifier
application number: M017
Careland Pain Relief PlusCAMPHOR, MENTHOL, METHYL SALICYLATEPlanet (Anhui) Pharmaceutical Co., Ltd.d9e63ddd-d003-45fa-b156-7f4452c28cbd2025-12-12WarningsExact identifier
application number: M017
Glucosamine Cream EXTRA STRENGTHHISTAMINE DIHYDROCHLORIDEIDEAZ, LLCf4d414b7-89e7-ad65-e053-2a95a90a25d42025-12-12WarningsExact identifier
application number: M017
ARTHRITISMENTHOLSmith Amish, LLC20c36972-b695-1241-e063-6394a90adf632025-12-12WarningsExact identifier
application number: M017
FOOTMENTHOLSmith Amish, LLC20c48537-f55f-c10f-e063-6394a90a4cca2025-12-12WarningsExact identifier
application number: M017
Joint EaseMENTHOLSmith Amish, LLC20c4a0f8-bdc6-d89a-e063-6294a90aa8d82025-12-12WarningsExact identifier
application number: M017
Toast Screamin HotCAPSAICINIDEAZ, LLC331207e6-b8ac-b169-e063-6394a90ac1692025-12-12WarningsExact identifier
application number: M017
Pain Relief Gel-PatchLIDOCAINEKORVIA GLOBAL Inc.45ccfcae-a307-1c5f-e063-6294a90acf892025-12-12WarningsExact identifier
application number: M017
Lidospot patchLIDOCAINE AND MENTHOLFabrication Enterprises Inc3a6e94c4-1ca6-e77a-e063-6394a90a4bfc2025-12-12WarningsExact identifier
application number: M017
LETEBEE LIGHT neuropathy pain relief cream for feetMENTHOLGuangdong Aimu Biological Technology Co., Ltd45a99afc-15ec-76c2-e063-6294a90a22202025-12-11WarningsExact identifier
application number: M017
CintheraLIDOCAINEStrand Health Group2746e5b2-be2d-f2d2-e063-6394a90a36902025-12-11WarningsExact identifier
application number: M017
Equate Cool and Heat Pain Relieving LiquidCOOL AND HEAT PAIN RELIEFWalmart, Inc.ad156685-3bd5-6837-e053-2995a90ac7882025-12-11WarningsExact identifier
application number: M017
HUMCO Camphor SpiritCAMPHOR 10%Humco Holding Group, Inc.9a0ef0a3-3c79-41b2-8193-424a3ef9886f2025-12-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807136camphor 9.6 % / capsaicin 0.05 % / menthol 7.8 % Medicated PatchPSN3b6155a5-51aa-2780-e054-00144ff8d46c5
1807136camphor 0.096 MG/MG / capsaicin 0.0005 MG/MG / menthol 0.078 MG/MG Medicated PatchSCD3b6155a5-51aa-2780-e054-00144ff8d46c5
1807136camphor 9.6 % / capsaicin 0.05 % / menthol 7.8 % Medicated PatchSY3b6155a5-51aa-2780-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70927-001-00709270001004 g in 1 PATCH (70927-001-00) 4 g2016-08-250000-00-00NoNoCurrent