Pain Be Gone

Product NDC
82721-001
11-digit product format
827210001
Labeler code
82721
Product ID
82721-001_2ce15484-38f2-014d-e063-6294a90aced2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
CREAM
Route
TOPICAL
Labeler
Back to Earth Inc.
Application
M014
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-27
Substance
MENTHOL
Active strength
9.6 mg/mL
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
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82721-001-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage82721-001-02ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82721-001-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage82721-001-020efc9e666f02…f202fb6c5f17…

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 Be Gone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL9.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f49e718b-ef89-b648-e053-2a95a90a96c8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82721-001-01Pain Be Gone50 mL in 1 TUBECREAM503
82721-001-02Pain Be Gone120 mL in 1 TUBECREAM1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82721-001PAIN BE GONE (MENTHOL) CREAM [BACK TO EARTH INC.]3Current NDC, 2 package rows20250130_f49e718b-ef89-b648-e053-2a95a90a96c8.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 1 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClearCanal Ear Wax Softerner DropsCARBAMIDE PEROXIDENeilMed Pharmaceuticals, Inc.0ef2be5b-cc39-48ae-b5c5-e787464dea082026-08-17WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC54dc3642-0b7a-07d8-e063-6294a90ad5562026-07-22WarningsExact identifier
application number: M014
EarBalance Ear Pain DropsLIDOCAINE HYDROCHLORIDE OTIC SOLUTIONMarie's Original Formulas LLC55057e1b-b11e-51b9-e063-6394a90a9fca2026-07-22WarningsExact identifier
application number: M014
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
application number: M014
Macks Dry n ClearEAR DRYING AIDMcKeon Products Inc1ea1da54-2412-c25c-e063-6294a90aa2642026-06-26WarningsExact identifier
application number: M014
Equate Swimmers Instant Ear DryEQUATE SWIMMERS INSTANT EAR DRYWalmart Stores, Inc76b58a7a-48cf-866c-e053-2a91aa0a7e632026-06-26WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Drops Earwax Removal AidCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.c68b40d9-c1d4-4425-8063-50c00299e7182026-06-10WarningsExact identifier
application number: M014
Quality Choice Earwax Removal Kit Earwax Removal Aid and BulbCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.b2a641da-e070-4223-b836-5ca9ffb89f3f2026-06-10WarningsExact identifier
application number: M014
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
application number: M014
CVS Health Earwax Removal KitCARBAMIDE PEROXIDECVS Pharmacy, Inc.f842534c-46dd-42c7-8386-9a03ce16da862026-05-29WarningsExact identifier
application number: M014
Lucid Hearing Earwax Removal Kit and BulbCARBAMIDE PEROXIDEHearing Lab Technology LLC5e09f566-397f-44d6-8ba2-90987765c7372026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax RemovalCARBAMIDE PEROXIDEAmerisource Bergend503b10f-85cd-4bb8-9dec-82d651d525fa2026-05-29WarningsExact identifier
application number: M014
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
application number: M014
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
application number: M014
Menthol Pain Relieving GelPAIN RELIEVING GELNeilMed Pharmaceuticals Inc513a206c-bbf6-3e51-e063-6294a90adf7a2026-05-07WarningsExact identifier
application number: M014
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
application number: M014
Freskaro Earwax Removal AidCARBAMIDE PEROXIDE 6.50% KITPharma Nobis, LLC4f5967ee-bc05-341c-e063-6394a90a35c62026-04-15WarningsExact identifier
application number: M014
GoodSense Ear Wax Removal KitCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.9a4198d2-cbea-466a-a252-d5c63d9ea0c12026-04-09WarningsExact identifier
application number: M014
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEPreferred Pharmaceuticals Inc.52f733a7-1301-4078-9267-5ce95b006ccc2026-04-09WarningsExact identifier
application number: M014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82721-001-018272100010150 mL in 1 TUBE (82721-001-01) 50 ml2023-07-27NoNoCurrent
82721-001-0282721000102120 mL in 1 TUBE (82721-001-02) 120 ml2023-07-27NoNoCurrent