Stressa Back and Neck Pain Relieving

Product NDC: 53882-001
11-digit product format: 538820001
Labeler code: 53882
Product ID: 53882-001_6e022f69-388e-49e9-867e-78a7e57c8ede
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Stressa Incorporated
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-12-03
Marketing end: 0000-00-00
Substance: MENTHOL
Active strength: 1 g/100g
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53882-001		I	Inactivated by FDA	2026-10-05
excluded package	package	53882-001	53882-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	53882-001	53882-001-04	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 · 66 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	53882-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53882-001-04	`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	53882-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53882-001-04	`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	53882-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53882-001-04	`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	53882-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53882-001-04	`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	53882-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53882-001-04	`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	53882-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53882-001-04	`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	53882-001-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53882-001-04	`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	53882-001-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53882-001-04	`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	53882-001-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53882-001-04	`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	53882-001-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53882-001-04	`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	53882-001-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53882-001-04	`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	53882-001-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53882-001-04	`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	53882-001-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53882-001-04	`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	53882-001-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53882-001-04	`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	53882-001-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53882-001-04	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53882-001-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53882-001-04	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53882-001-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53882-001-04	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53882-001-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53882-001-04	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53882-001-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53882-001-04	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53882-001-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53882-001-04	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53882-001-02	2019-11-27	C162847	48780-1	9855d018-d6be-cd31-e053-dbdaa90ab51a	Stressa™ Back & Neck Pain Relieving Cream
53882-001-04	2019-11-27	C162847	48780-1	9855d018-d6be-cd31-e053-dbdaa90ab51a	Stressa™ Back & Neck Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53882-001-01	Stressa Back and Neck Pain Relieving	43 g in 1 JAR	CREAM	43	1
53882-001-02	Stressa Back and Neck Pain Relieving	1 in 1 BOX	CREAM	1	1
53882-001-03	Stressa Back and Neck Pain Relieving	85 g in 1 JAR	CREAM	85	1
53882-001-04	Stressa Back and Neck Pain Relieving	1 in 1 BOX	CREAM	1	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) CREAM [STRESSA INCORPORATED]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
ARABICA COFFEE OIL	INACTIVE INGREDIENT	IK55HKE887	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Basil oil	INACTIVE INGREDIENT	Z129UMU8LE	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
CANANGA OIL	INACTIVE INGREDIENT	8YOY78GNNX	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Galbanum oil	INACTIVE INGREDIENT	211UF7M8N1	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Hyssop oil	INACTIVE INGREDIENT	173D71924B	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
lemon oil	INACTIVE INGREDIENT	I9GRO824LL	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Nutmeg oil	INACTIVE INGREDIENT	Z1CLM48948	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
palm oil	INACTIVE INGREDIENT	5QUO05548Z	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
PICEA MARIANA LEAF OIL	INACTIVE INGREDIENT	Q1J49L1A5O	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Rosemary oil	INACTIVE INGREDIENT	8LGU7VM393	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
Sage oil	INACTIVE INGREDIENT	U27K0H1H2O	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
shea butter	INACTIVE INGREDIENT	K49155WL9Y	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
sunflower oil	INACTIVE INGREDIENT	3W1JG795YI	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
tocopherol	INACTIVE INGREDIENT	R0ZB2556P8	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
water	INACTIVE INGREDIENT	059QF0KO0R	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1
white wax	INACTIVE INGREDIENT	7G1J5DA97F	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53882-001	STRESSA BACK AND NECK PAIN RELIEVING (MENTHOL) CREAM [STRESSA INCORPORATED]	1	Legacy NDC, 4 package rows	20121207_96372b6d-8346-480a-b292-958dd874b158.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
416982	menthol 1.25 % Topical Cream	PSN	96372b6d-8346-480a-b292-958dd874b158	1
416982	menthol 12.5 MG/ML Topical Cream	SCD	96372b6d-8346-480a-b292-958dd874b158	1
416982	menthol 1.25 % Topical Cream	SY	96372b6d-8346-480a-b292-958dd874b158	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53882-001-01	53882000101	43 g in 1 JAR	43 g	Historical
53882-001-02	53882000102	1 in 1 BOX		Historical
53882-001-03	53882000103	85 g in 1 JAR	85 g	Historical
53882-001-04	53882000104	1 in 1 BOX		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Stressa™ Back & Neck Pain Relieving Cream	Stressa Incorporated	2012-12-05	HUMAN OTC DRUG LABEL	1