FDA.reportPublic FDA data

Large Medicate Relief Patches

Product NDC
46122-645
11-digit product format
461220645
Labeler code
46122
Product ID
46122-645_4694b735-e565-5a62-e063-6394a90a64e3
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
Amerisource Bergen
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength
3.1; 6; 10 g/100g; g/100g; g/100g
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage46122-645-13fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage46122-645-1386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage46122-645-13bd6a592717d7…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
Large Medicate Relief Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.1 g/100g
MENTHOL6 g/100g
METHYL SALICYLATE10 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup
LAV5U5022YInternal 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
a7d5f89b-59b9-4603-99aa-273b85be813eAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46122-645-132022-12-16C16284748780-1d6a99b39-dc60-a426-e053-dadaa90af4c2Good Neighbor Medicated Relief Patches
46122-645-132022-01-28C16284748780-1d6a99b39-dc60-a426-e053-dadaa90af4c2Good Neighbor Medicated Relief Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-645-13Large Medicate Relief Patches6 in 1 BOXPATCH64
46122-645-13Large Medicate Relief Patches9 g in 1 PATCHPATCH94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-645-13EA - Each46122-645081cb258-fbd2-4a2e-a60f-05815263979912021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-645LARGE MEDICATE RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20241220_a7d5f89b-59b9-4603-99aa-273b85be813e.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 107 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DCH Calaspray Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Derma Care Research Labs, LLCfda2afaf-3cd0-92b3-e053-6394a90a74932024-12-19WarningsExact identifier
application number: M017
DCH Nerve Pain Relief Roll-OnLIDOCAINE HCL 4%, MENTHOL 1%Derma Care Research Labs, LLCff32cbb2-79eb-9158-e053-6394a90ac3572024-12-19WarningsExact identifier
application number: M017
DCH Burn ReliefLIDOCAINE, 0.5%Derma Care Research Labsffd7be08-0510-dfcb-e053-6394a90ad2862024-12-19WarningsExact identifier
application number: M017
DCH Arthritis Pain Relief Roll-OnCAPSAISIN 0.1%Derma Care Research Labs, LLCfda0d359-95eb-8b38-e053-6294a90a7b882024-12-19WarningsExact identifier
application number: M017
DCH Pain RelievingMENTHOL 2%Derma Care Research Labs, LLCff49ee63-6a87-c7a7-e053-6294a90a77a32024-12-19WarningsExact identifier
application number: M017
Warrior Pain Relief Roll-On Maximum StrengthLIDOCAINE HCL 4%Derma Care Research Labs, LLCdd80e560-6467-2166-e053-2995a90a88a82024-12-19WarningsExact identifier
application number: M017
DCH Labs Cool and Heat Roll-OnMENTHOL 16%Derma Care Research Labs, LLCd35d7720-44ce-3624-e053-2995a90a7fb42024-12-19WarningsExact identifier
application number: M017
Dr Goldsons PainMENTHOL 8%, METHYL SALICYLATE 30%Derma Care Research Labs, LLCfb34b0d3-ccc0-305e-e053-6394a90a231d2024-12-19WarningsExact identifier
application number: M017
Warrior Pain RelievingCAMPHOR 4%, MENTHOL 10%, METHYL SALICYLATE 30%Derma Care Research Labs, LLCdd06af3c-5452-9759-e053-2a95a90afc212024-12-19WarningsExact identifier
application number: M017
Warrior Burn Relief Aloe Maximum StrengthLIDOCAINE HCL 4%Derma Care Research Labs, LLCec6efa4b-dcbe-1c2b-e053-2995a90ae0432024-12-19WarningsExact identifier
application number: M017
DCH Arthritis ReliefTROLAMIN SALICYLATE 10%Derma Care Research Labs, LLCff31e515-5780-b77d-e053-6394a90af6b92024-12-19WarningsExact identifier
application number: M017
DCH Pain ReliefLIDOCAINE 4%Derma Care Research Labs, LLC00efda74-d434-04be-e063-6294a90a6d982024-12-19WarningsExact identifier
application number: M017
Dollar General Cold Therapy Pain ReliefMENTHOL 5%Dolgencorp, LLCff3284d1-e73c-93bf-e053-6294a90aaf4e2024-12-19WarningsExact identifier
application number: M017
Dollar General Pain Relieving Patch with LidocaineLIDOCAINEDOLGENCORP, LLC55828cd1-3a1e-48ac-bb01-4c50b96d09a22024-12-19WarningsExact identifier
application number: M017
DCH Nerve Pain ReliefLIDOCAINE 4%, MENTHOL 1%Derma Care Research Labs, LLC00db480a-e510-a64d-e063-6394a90a46952024-12-19WarningsExact identifier
application number: M017
Pain, Burn, and Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Derma Care Research Labs, LLCfd9fe09f-3ae9-c5f5-e053-6394a90ad6912024-12-19WarningsExact identifier
application number: M017
DCH Cooling Pain ReliefMENTHOL 4%Derma Care Research Labs, LLC00ed3175-c3ba-6545-e063-6394a90acfd12024-12-19WarningsExact identifier
application number: M017
DCH Pain ReliefLIDOCAINE HCL 4%Derma Care Research Labs, LLC00dd70f3-ecc3-33ba-e063-6294a90a4f322024-12-19WarningsExact identifier
application number: M017
Walgreens Kinesiology Pain ReliefLIDOCAINE, MENTHOLWalgreen Co.0fdbb310-8e65-4e0c-b413-a093964324a22024-12-19WarningsExact identifier
application number: M017
Signature Care Medicated Cold and Hot PatchMENTHOLSafeway0335f1b3-5c8a-67b8-e063-6294a90a98472024-12-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSNa7d5f89b-59b9-4603-99aa-273b85be813e4
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCDa7d5f89b-59b9-4603-99aa-273b85be813e4
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSYa7d5f89b-59b9-4603-99aa-273b85be813e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-645-13461220645136 PATCH in 1 BOX (46122-645-13) / 9 g in 1 PATCH6 patch2020-01-010000-00-00NoNoCurrent