FDA.reportPublic FDA data

Pain Relief Patches

Product NDC
46122-392
11-digit product format
461220392
Labeler code
46122
Product ID
46122-392_598412f5-3837-bbf9-e063-6394a90a6784
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
2018-01-01
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-39246122-392-58DDiscontinued by firm2026-10-23
excluded packagepackage46122-39246122-392-72DDiscontinued by firm2026-10-23

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 · 12 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 packagepackage46122-392-58fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage46122-392-60fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage46122-392-72fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage46122-392-5886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage46122-392-6086f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage46122-392-7286f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage46122-392-58bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage46122-392-60bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage46122-392-72bd6a592717d7…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 Relief Patches
Listing expiration
2027-12-31

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
5fb5e5ce-b268-4444-8b63-ea7ea6abf269Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
46122-392-582022-12-16Good Neighbor Medicated Relief Patches
46122-392-582022-12-16Good Neighbor Medicated Relief Patches
46122-392-602022-12-16Good Neighbor Medicated Relief Patches
46122-392-602022-12-16Good Neighbor Medicated Relief Patches
46122-392-722022-12-16Good Neighbor Medicated Relief Patches
46122-392-722022-12-16Good Neighbor Medicated Relief Patches
46122-392-582022-01-28Good Neighbor Medicated Relief Patches
46122-392-582022-01-28Good Neighbor Medicated Relief Patches
46122-392-602022-01-28Good Neighbor Medicated Relief Patches
46122-392-602022-01-28Good Neighbor Medicated Relief Patches
46122-392-722022-01-28Good Neighbor Medicated Relief Patches
46122-392-722022-01-28Good Neighbor Medicated Relief Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-392-58Pain Relief Patches9 g in 1 PATCHPATCH96
46122-392-58Pain Relief Patches40 in 1 BOXPATCH406
46122-392-60Pain Relief Patches20 in 1 BOXPATCH206
46122-392-60Pain Relief Patches9 g in 1 PATCHPATCH96
46122-392-72Pain Relief Patches60 in 1 BOXPATCH606
46122-392-72Pain Relief Patches9 g in 1 PATCHPATCH96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-392-58EA - Each46122-39273a91acd-f7c8-4ba3-88a2-0458043bfd4712020-05-08
46122-392-60EA - Each46122-392848ee7f5-1f8a-4545-b324-da57955327e512022-06-06
46122-392-72EA - Each46122-39217ab1da1-a68f-426f-ba31-fd1b5fa36c5312020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-392PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [AMERISOURCE BERGEN]5Current NDC, Legacy NDC, 6 package rows20241220_5fb5e5ce-b268-4444-8b63-ea7ea6abf269.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 149 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SCLERA CARE Topical Anesthetic GelLIDOCAINE HYDROCHLORIDEScleraCare, LLC488ace02-fc0b-4d13-ab89-0e1640e915e52023-11-05WarningsExact identifier
application number: M017
IRELIEV ROLL ON COOL PAIN RELIEFMENTHOLExcel Health, Incdab94995-7393-4d9c-b295-72611a90919b2023-11-05WarningsExact identifier
application number: M017
URIFLEX Fast Acting Analgesic Pain ReliefMENTHOLRejuvica LLCfb78f705-b838-461d-b42c-8c98d3ca5d092023-11-05WarningsExact identifier
application number: M017
365 Medicated Lip BalmMEDICATED LIP BALMWhole Foods Market, Inc.48309a7d-d2da-483c-8bf8-f59d9ad0bb732023-11-03WarningsExact identifier
application number: M017
COOL BREEZE Pain ReliefMENTHOLCOOL BREEZE US LLC14dcf4ee-6778-49d4-8601-9205737432ea2023-11-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP1ebb45e5-4541-4c95-abe1-661ef763a6102023-11-01WarningsExact identifier
application number: M017
Walgreens Pain Relieving CreamLIDOCAINE 4%Walgreensce1b55ed-f5c5-ea8b-e053-2a95a90acd402023-10-31WarningsExact identifier
application number: M017
Walgreens pain relievingLIDOCAINE 4%Walgreensce2b9e57-749d-715c-e053-2995a90aaf8d2023-10-31WarningsExact identifier
application number: M017
Walgreens Cool n heatLIDOCAINE 4% MENTHOL 1%Walgreensce168ab7-ec4a-daea-e053-2995a90af8292023-10-31WarningsExact identifier
application number: M017
Methyl Salicylate 40 PercentMETHYL SALICYLATEAlexso, Inc53407aab-094c-4393-a2b9-54fd85321e3e2023-10-31WarningsExact identifier
application number: M017
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN5fb5e5ce-b268-4444-8b63-ea7ea6abf2696
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD5fb5e5ce-b268-4444-8b63-ea7ea6abf2696
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY5fb5e5ce-b268-4444-8b63-ea7ea6abf2696

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-392-584612203925840 PATCH in 1 BOX (46122-392-58) > 9 g in 1 PATCH40 patch2018-01-010000-00-00NoNoCurrent
46122-392-604612203926020 PATCH in 1 BOX (46122-392-60) / 9 g in 1 PATCH20 patch2018-01-012026-12-10NoNoCurrent
46122-392-724612203927260 PATCH in 1 BOX (46122-392-72) > 9 g in 1 PATCH60 patch2018-01-010000-00-00NoNoCurrent