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 100 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hempvana Maximum Strength Pain Relief Cream ExtremeMENTHOL 16%, CAMPHOR 11%Telebrands Corp2d54077e-4c8d-aaae-e063-6394a90adb412025-02-04WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINNuCare Pharmaceuticals,Inc.fd90a67d-d60d-a849-e053-6394a90a2cc82025-02-04WarningsExact identifier
application number: M017
Rugby Muscle Rub CreamMUSCLE RUB CREAMNuCare Pharmaceuticals, Inc.2d58c15a-5ddb-1b16-e063-6294a90a3fbb2025-02-04WarningsExact identifier
application number: M017
CetilarMENTHOL 1.4%PharmaNutra Usa Corp.2dd14bd4-b4e1-bc7d-e063-6394a90a1e592025-02-04WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.0d199d39-5b47-4c7f-b83a-757f39aa17b62025-02-03WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare2d42192b-8889-a896-e063-6294a90a4fc82025-02-03WarningsExact identifier
application number: M017
Tiger Balm Pain Relieving MuscleMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.96b06d3f-8685-4314-ad7d-5d2720f4dde62025-02-03WarningsExact identifier
application number: M017
Icy Hot Medicated No Mess ApplicatorMENTHOLChattem, Inc.4ce2b823-7ef5-4cca-a2d8-2fe781bc958e2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing Itch Relief CreamHYDROCORTISONEChattem, Inc.cdbeb825-3152-4f74-9fd1-93bccfc0e31a2025-02-01WarningsExact identifier
application number: M017
Cortizone 10 Soothing Aloe Itch ReliefHYDROCORTISONEChattem, Inc.1962abb3-6ca7-4934-9efe-20287b1c2a5b2025-02-01WarningsExact identifier
application number: M017
myDerm Cooling Menthol Pain Relief with 50 Percent More MentholMENTHOLInspec Solutions LLCd4276749-eeff-28f7-e053-2a95a90a593d2025-01-31WarningsExact identifier
application number: M017
MyDerm Bite ReliefBENZOCAINEInspec Solutions LLC.88615668-16b5-7840-e053-2a95a90a92082025-01-31WarningsExact identifier
application number: M017
Maximum Strength Blue Emu Pain Relief Blu EmuTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLC5e02b820-e53a-42cb-abdb-2925617c29ca2025-01-31WarningsExact identifier
application number: M017
Sunset Novelties HerquakeNUMBING LUBRICANTSUNSET INTIMATES GROUP INC2ceeca3e-9197-9166-e063-6394a90ae9082025-01-30WarningsExact identifier
application number: M017
Magsoothium CBD Cooling Roll on ReliefMENTHOLUbu/Elements, Inc.2cf05dcd-6a44-de08-e063-6394a90aaba02025-01-30WarningsExact identifier
application number: M017
Meijer Vagicaine20% BENZOCAINE AND 3% RESORCINOL CREAMMeijer, Inc.dac73a07-7569-4788-977a-f10d098da75d2025-01-30WarningsExact identifier
application number: M017
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINE 4%Noble OTC LLC12a3ce63-6fce-0993-e063-6294a90a40d52025-01-28WarningsExact identifier
application number: M017
INTIMALE LIDOCAINE DELAYLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED5ddd7d56-bf51-462b-afcd-944861e497812025-01-28WarningsExact identifier
application number: M017
CBD Clinic Relax MassageCAMPHORABACUS HEALTH PRODUCTS, INC.f0eae24e-09cf-0d2d-e053-2a95a90acedc2025-01-28WarningsExact 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