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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82721-001-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82721-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82721-001-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82721-001-02	`0efc9e666f02…`	`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
Ingredient	Strength
MENTHOL	9.6 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f49e718b-ef89-b648-e053-2a95a90a96c8	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82721-001-01	Pain Be Gone	50 mL in 1 TUBE	CREAM	50		3
82721-001-02	Pain Be Gone	120 mL in 1 TUBE	CREAM	120		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82721-001	PAIN BE GONE (MENTHOL) CREAM [BACK TO EARTH INC.]	3	Current NDC, 2 package rows	20250130_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 4 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Best Choice Earwax Removal Drops	CARBAMIDE PEROXIDE	Valu Merchandisers Company	3ae6255f-f494-412b-af76-3579de08ed23	2025-02-28	Warnings	Exact identifier application number: M014
Equaline Earwax Removal Drops	CARBAMIDE PEROXIDE	United Natural Foods	d853567a-ce8d-40a8-be1e-27176802ff64	2025-02-28	Warnings	Exact identifier application number: M014
Family Wellness Earwax Removal Earwax and Bulb	CARBAMIDE PEROXIDE	Family Dollar Services Inc	26ebf208-4710-4af2-aa2d-b2040b85cf85	2025-02-28	Warnings	Exact identifier application number: M014
FOSTER AND THRIVE EARWAX REMOVAL DROPS	CARBAMIDE PEROXIDE	A-S Medication Solutions	0a571ae8-237b-447d-b697-02b30692b6b1	2025-02-24	Warnings	Exact identifier application number: M014
Pain Be Gone	MENTHOL	Back to Earth Inc.	f49e718b-ef89-b648-e053-2a95a90a96c8	2025-01-29	Warnings	Exact identifier application number: M014 ndc (product): 82721-001
DEBROX	CARBAMIDE PEROXIDE	Medtech Products Inc.	43649ba3-75e0-4dcf-9172-23767dbaeda6	2025-01-27	Warnings	Exact identifier application number: M014
HylaTears	EYE DROPS	Hyalogic LLC	2b5fc4c4-843c-8d3d-e063-6394a90a5a1b	2025-01-10	Warnings	Exact identifier application number: M014
BODYOGRAPHYPRO ANTI-BACTERIAL SANITIZING	ETHYL ALCOHOL	Robanda International, Inc.	ebec43d4-4676-40f9-b989-5381f4a737c8	2025-01-08	Warnings	Exact identifier application number: M014
Dr. Talbots	ETHYL ALCOHOL	Talbots Pharmaceuticals Family Products, LLC.	a6a94205-a9ff-7709-e053-2995a90a066b	2025-01-08	Warnings	Exact identifier application number: M014
Foster and Thrive Earwax Removal Kit Ear wax drops	CARBAMIDE PEROXIDE	Mckesson Corp. Via Strategic Sourcing Services	c9bd4c1f-b3b8-4bdc-b529-3a98b657e628	2024-12-31	Warnings	Exact identifier application number: M014
Foster and Thrive Earwax Removal Drops	CARBAMIDE PEROXIDE	Mckesson Corp. Via Strategic Sourcing Services	6180835c-d7a7-4bf7-95cb-0fd3c8140253	2024-12-31	Warnings	Exact identifier application number: M014
OIDO SANA	ISOPROPYL ALCOHOL	ProMex LLC	71e84695-49e8-459f-ac5e-118b5235fe06	2024-12-18	Warnings	Exact identifier application number: M014
ERO Ear Wax Removal Kit	CARBAMIDE PEROXIDE 6.5%	Randob Labs	fbf8a6f2-531d-5047-e053-6294a90aaa01	2024-12-15	Warnings	Exact identifier application number: M014
Harris Teeter Earwax Removal Drops	CARBAMIDE PEROXIDE 6.5%	Harris Teeter LLC	dda4c4bf-425e-4fff-e053-2a95a90a51bc	2024-12-15	Warnings	Exact identifier application number: M014
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Mazza Healthcare, LLC	ee83ba9f-ac65-48b7-9f84-5be6fec9a909	2024-11-21	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops Up and Up	CARBAMIDE PEROXIDE - 6.5%	Target Corporation	829ece50-1f26-4f69-b000-010a34d4cd54	2024-11-21	Warnings	Exact identifier application number: M014
Walgreens Ear Wax Remover	CARBAMIDE PEROXIDE 6.5%	Walgreens Company	d3b7362b-2826-4b86-bfa3-ef302dc79143	2024-11-20	Warnings	Exact identifier application number: M014
CLEARCANAL EAR WAX SOFTERNER DROPS	CARBAMIDE PEROXIDE	A-S Medication Solutions	ac3d57a4-08d5-45f1-be84-f68eef9d1398	2024-11-04	Warnings	Exact identifier application number: M014
Caladryl Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Bausch Health US, LLC	fca6f08b-7fa0-4ae6-bce3-61f3bcae4332	2024-10-17	Warnings	Exact identifier application number: M014
Caladryl	FERRIC OXIDE RED, ZINC OXIDE, AND PRAMOXINE HYDROCHLORIDE	Bausch Health US, LLC	67d4fd42-9fed-4238-9f5a-c9403abbcf20	2024-10-17	Warnings	Exact identifier application number: M014

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82721-001-01	82721000101	50 mL in 1 TUBE (82721-001-01)	50 ml	2023-07-27	No	No	Current
82721-001-02	82721000102	120 mL in 1 TUBE (82721-001-02)	120 ml	2023-07-27	No	No	Current