Pain Release

Product NDC: 70983-006
11-digit product format: 709830006
Labeler code: 70983
Product ID: 70983-006_48511d13-43c4-cc16-e063-6394a90a8458
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: OIL
Route: TOPICAL
Labeler: Saje Natural Business Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-10-16
Substance: MENTHOL
Active strength: 17.62 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	17.62 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
3df0e56a-7651-42dc-8ed8-f68836a63c61	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70983-006-03	Pain Release	1 in 1 BOX	OIL	1	5
70983-006-03	Pain Release	30 mL in 1 BOTTLE, DROPPER	OIL	30	5
70983-006-04	Pain Release	10 mL in 1 BOTTLE, DROPPER	OIL	10	5
70983-006-04	Pain Release	1 in 1 BOX	OIL	1	5
70983-006-05	Pain Release	6 mL in 1 BOTTLE, DROPPER	OIL	6	5
70983-006-05	Pain Release	1 in 1 BOX	OIL	1	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70983-006	PAIN RELEASE (MENTHOL) OIL [SAJE NATURAL BUSINESS INC.]	4	Current NDC, Legacy NDC, 6 package rows	20231006_3df0e56a-7651-42dc-8ed8-f68836a63c61.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 151 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bactine Max Antibiotic and Lidocaine Max Pain Relief	LIDOCAINE	WellSpring Pharmaceutical Corporation	71300df9-6113-4f25-93ca-28ad7e7f79de	2023-06-08	Warnings	Exact identifier application number: M017
Bactine Max Lidocaine Roll-on 2.5oz	LIDOCAINE	WellSpring Pharmaceutical Corporation	09b32a98-9131-451e-87a6-81a1e4ed7ec5	2023-04-25	Warnings	Exact identifier application number: M017
Icy Hot Pro Dry	CAMPHOR, MENTHOL	Chattem, Inc.	4de1bc29-d166-4599-9e75-5f841bf20967	2023-03-01	Warnings	Exact identifier application number: M017
Icy Hot Vanishing Scent	MENTHOL	Chattem, Inc.	e2092016-9741-433d-92e6-74bfddadb72c	2022-09-29	Warnings	Exact identifier application number: M017
New Terocin	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	Alexso, Inc	5dbd5fc0-a27e-4979-aca7-28f73096fd5f	2022-08-18	Warnings	Exact identifier application number: M017
FIRSTAR Sting Relief Pad	BENZOCAINE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	0e491a7a-4204-439f-862d-741cbc0be9fd	2021-07-06	Warnings	Exact identifier application number: M017
Arthritis Relief GoodSense	TROLAMINE SALICYLATE	Geiss, Destin & Dunn, Inc	a253730a-2187-07de-e053-2a95a90a9877	2020-04-02	Warnings	Exact identifier application number: M017
Aloe Cort	HYDROCORTISONE	Topiderm, Inc.	789a6669-3320-4558-8d6f-ab255db50d8d	2019-09-17	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Refresh	CAMPHOR, MENTHOL	Borden Company (Private) Limited	567b6820-fb52-630e-e063-6294a90a8bf8	2015-07-01	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Oil Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	54e45d89-e8c3-6fc3-e063-6394a90aac4e	2015-06-15	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70983-006-03	70983000603	1 BOTTLE, DROPPER in 1 BOX (70983-006-03) / 30 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current
70983-006-04	70983000604	1 BOTTLE, DROPPER in 1 BOX (70983-006-04) / 10 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current
70983-006-05	70983000605	1 BOTTLE, DROPPER in 1 BOX (70983-006-05) / 6 mL in 1 BOTTLE, DROPPER	2016-10-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pain Release Oil Blend (30 ml, 10 ml, 6 ml)	Saje Natural Business Inc. \| Natures Formulae Health Products Ltd.	2026-01-12	HUMAN OTC DRUG LABEL	5