Pain Relieving

Product NDC
68678-039
11-digit product format
686780039
Labeler code
68678
Product ID
68678-039_3dd5f9fd-158e-7307-e063-6394a90a1b5d
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, Camphor, Capsaicin
Dosage form
LOTION
Route
TOPICAL
Labeler
AHC VENTURES CORP DBA CRY
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
MENTHOL; CAMPHOR (SYNTHETIC); CAPSAICIN
Active strength
3.85; 3.85; .0355 g/100mL; g/100mL; g/100mL
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 2 · 74 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68678-039-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68678-039-99f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68678-039-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68678-039-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68678-039-992ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68678-039-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68678-039-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68678-039-99a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68678-039-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68678-039-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68678-039-99cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68678-039-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68678-039-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68678-039-99cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68678-039-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68678-039-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68678-039-99302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68678-039-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68678-039-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68678-039-99ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68678-039-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68678-039-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68678-039-990efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68678-039-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68678-039-04ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68678-039-99ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68678-039-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68678-039-04367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68678-039-99367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68678-039-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68678-039-04557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68678-039-99557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68678-039-16557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68678-039-048af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68678-039-998af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68678-039-168af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68678-039-04834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68678-039-99834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68678-039-16834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68678-039-041332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68678-039-991332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68678-039-161332a3947898…d4bfe170f9cd…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68678-039-1686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68678-039-0486f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…

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
Pain Relieving
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3.85 g/100mL
CAMPHOR (SYNTHETIC)3.85 g/100mL
CAPSAICIN.0355 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
5TJD82A1ETInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
27679d31-a5f3-417b-b0c5-5f6b001ecff9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-039-04Pain Relieving112 mL in 1 BOTTLE, DISPENSINGLOTION1125
68678-039-16Pain Relieving449 mL in 1 BOTTLE, DISPENSINGLOTION4495
68678-039-99Pain Relieving3.35 mL in 1 PACKETLOTION3.355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-039PAIN RELIEVING (MENTHOL, CAMPHOR, CAPSAICIN) LOTION [AHC VENTURES CORP DBA CRY]4Current NDC, Legacy NDC, 3 package rows20220511_27679d31-a5f3-417b-b0c5-5f6b001ecff9.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 59 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsExact identifier
application number: M017
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ONCAMPHORSUNSET NOVELTIES, INC45048936-f3c9-25f7-e063-6394a90ac4a92025-12-02WarningsExact identifier
application number: M017
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
application number: M017
CareALL Arthritis and MuscleCAPSAICINNew World Imports, Inc4867eac4-00ea-434e-b289-1c1ef0342c232025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68678-039-0468678003904112 mL in 1 BOTTLE, DISPENSING (68678-039-04) 112 ml2016-01-010000-00-00NoNoCurrent
68678-039-1668678003916449 mL in 1 BOTTLE, DISPENSING (68678-039-16) 449 ml2016-01-010000-00-00NoNoCurrent
68678-039-99686780039993.35 mL in 1 PACKET (68678-039-99) 3.35 ml2016-01-010000-00-00NoNoCurrent