Stressa Back and Neck Pain Relieving

Product NDC: 53882-002
11-digit product format: 538820002
Labeler code: 53882
Product ID: 53882-002_11f9d65c-4717-4802-a8d9-921d4006c9ae
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: OIL
Route: TOPICAL
Labeler: Stressa Incorporated
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-08-01
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 1 g/93mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53882-002		I	Inactivated by FDA	2026-10-05
excluded package	package	53882-002	53882-002-01	I	Inactivated by FDA	2026-10-05
excluded package	package	53882-002	53882-002-02	I	Inactivated by FDA	2026-10-05
excluded package	package	53882-002	53882-002-03	I	Inactivated by FDA	2026-10-05

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 2 · 88 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53882-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53882-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53882-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53882-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53882-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53882-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53882-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53882-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53882-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53882-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53882-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53882-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53882-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53882-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53882-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53882-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53882-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53882-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53882-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53882-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53882-002-03	`302b2466d912…`	`e7b80fea0513…`
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	53882-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53882-002-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53882-002-03	`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	53882-002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53882-002-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53882-002-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53882-002-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53882-002-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53882-002-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53882-002-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53882-002-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53882-002-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53882-002-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53882-002-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53882-002-03	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53882-002-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53882-002-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53882-002-03	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53882-002-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53882-002-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53882-002-03	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53882-002-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53882-002-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53882-002-03	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53882-002-01	2019-11-27	C162847	48780-1	9855e2a2-4fc2-60a7-e053-dbdaa90a05bd	Stressa ™ Back & Neck Pain Relieving Oil
53882-002-02	2019-11-27	C162847	48780-1	9855e2a2-4fc2-60a7-e053-dbdaa90a05bd	Stressa ™ Back & Neck Pain Relieving Oil
53882-002-03	2019-11-27	C162847	48780-1	9855e2a2-4fc2-60a7-e053-dbdaa90a05bd	Stressa ™ Back & Neck Pain Relieving Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53882-002-01	Stressa Back and Neck Pain Relieving	60 mL in 1 BOTTLE, PLASTIC	OIL	60	1
53882-002-02	Stressa Back and Neck Pain Relieving	118 mL in 1 BOTTLE, PLASTIC	OIL	118	1
53882-002-03	Stressa Back and Neck Pain Relieving	240 mL in 1 BOTTLE, PLASTIC	OIL	240	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
APRICOT KERNEL OIL	INACTIVE INGREDIENT	54JB35T06A	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
ARABICA COFFEE OIL	INACTIVE INGREDIENT	IK55HKE887	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
BASIL OIL	INACTIVE INGREDIENT	Z129UMU8LE	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
CANANGA OIL	INACTIVE INGREDIENT	8YOY78GNNX	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
EUROPEAN HAZELNUT OIL	INACTIVE INGREDIENT	8RQ2839AVG	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
GALBANUM OIL	INACTIVE INGREDIENT	211UF7M8N1	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
HYSSOP OIL	INACTIVE INGREDIENT	173D71924B	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
LEMON OIL	INACTIVE INGREDIENT	I9GRO824LL	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
NUTMEG OIL	INACTIVE INGREDIENT	Z1CLM48948	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
PICEA MARIANA LEAF OIL	INACTIVE INGREDIENT	Q1J49L1A5O	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
ROSEMARY OIL	INACTIVE INGREDIENT	8LGU7VM393	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
SAGE OIL	INACTIVE INGREDIENT	U27K0H1H2O	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1
WHEAT GERM	INACTIVE INGREDIENT	YR3G369F5A	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53882-002	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) OIL [STRESSA INCORPORATED]	1	Legacy NDC, 3 package rows	20140813_8dc5dbff-a4d5-4b81-825b-25691cf9ac0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1545293	menthol 1.25 % Topical Oil	PSN	8dc5dbff-a4d5-4b81-825b-25691cf9ac0f	1
1545293	menthol 12.5 MG/ML Topical Oil	SCD	8dc5dbff-a4d5-4b81-825b-25691cf9ac0f	1
1545293	menthol 1.25 % Topical Oil	SY	8dc5dbff-a4d5-4b81-825b-25691cf9ac0f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53882-002-01	53882000201	60 mL in 1 BOTTLE, PLASTIC	60 ml	Historical
53882-002-02	53882000202	118 mL in 1 BOTTLE, PLASTIC	118 ml	Historical
53882-002-03	53882000203	240 mL in 1 BOTTLE, PLASTIC	240 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stressa ™ Back & Neck Pain Relieving Oil	Stressa Incorporated	2014-08-04	HUMAN OTC DRUG LABEL	1