Miracle Plus Overnight

Product NDC: 64058-155
11-digit product format: 640580155
Labeler code: 64058
Product ID: 64058-155_a56b263a-5d26-44fe-a476-4fc6ef6d3913
Type: HUMAN OTC DRUG
Nonproprietary name: Capsaicin
Dosage form: GEL
Route: TOPICAL
Labeler: Concept Laboratories, Inc.
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-11-20
Marketing end: 0000-00-00
Substance: CAPSAICIN
Active strength: 0 g/113g
NDC exclude flag: E
Listing certified through: 2018-12-31
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	64058-155		I	Inactivated by FDA	2026-11-02
excluded package	package	64058-155	64058-155-42	I	Inactivated by FDA	2026-11-02
excluded package	package	64058-155	64058-155-44	I	Inactivated by FDA	2026-11-02

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	64058-155-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	64058-155-42	`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	64058-155-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	64058-155-42	`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	64058-155-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	64058-155-42	`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	64058-155-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	64058-155-42	`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	64058-155-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	64058-155-42	`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	64058-155-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	64058-155-42	`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	64058-155-44	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	64058-155-42	`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	64058-155-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	64058-155-42	`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	64058-155-44	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	64058-155-42	`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	64058-155-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	64058-155-42	`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	64058-155-44	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	64058-155-42	`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	64058-155-44	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	64058-155-42	`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	64058-155-44	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	64058-155-42	`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	64058-155-44	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	64058-155-42	`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	64058-155-44	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	64058-155-42	`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	64058-155-44	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	64058-155-42	`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	64058-155-44	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	64058-155-42	`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	64058-155-44	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	64058-155-42	`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	64058-155-44	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	64058-155-42	`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	64058-155-44	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	64058-155-42	`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
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64058-155-42	2020-01-31	C162847	48780-1	9d75b9d0-6688-f424-e053-dadaa90a57ce	Miracle ® Plus Overnight Pain Relieving Gel
64058-155-44	2020-01-31	C162847	48780-1	9d75b9d0-6688-f424-e053-dadaa90a57ce	Miracle ® Plus Overnight Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64058-155-42	Miracle Plus Overnight Pain Relieving	57 g in 1 BOTTLE	GEL	57		1
64058-155-44	Miracle Plus Overnight Pain Relieving	113 g in 1 BOTTLE	GEL	113		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Capsaicin	ACTIVE INGREDIENT	S07O44R1ZM	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
Capsaicin	ACTIVE MOIETY	S07O44R1ZM	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
ALFALFA LEAF	INACTIVE INGREDIENT	HY3L927V6M	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
ASIAN GINSENG	INACTIVE INGREDIENT	CUQ3A77YXI	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
CYMBOPOGON SCHOENANTHUS LEAF	INACTIVE INGREDIENT	XF54B1Z2HF	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
EMU OIL	INACTIVE INGREDIENT	344821WD61	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
GINKGO	INACTIVE INGREDIENT	19FUJ2C58T	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
GLUCOSAMINE HYDROCHLORIDE	INACTIVE INGREDIENT	750W5330FY	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
PEG-75 LANOLIN	INACTIVE INGREDIENT	09179OX7TB	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64058-155	MIRACLE PLUS OVERNIGHT PAIN RELIEVING (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.]	1	Legacy NDC, 2 package rows	20141205_e2041558-6091-4093-9fc6-44a93df3f0d4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1373385	Capsicum oleoresin 0.0625 % Topical Gel	PSN	e2041558-6091-4093-9fc6-44a93df3f0d4	1
1373385	Capsicum oleoresin 0.000625 MG/MG Topical Gel	SCD	e2041558-6091-4093-9fc6-44a93df3f0d4	1
1373385	Capsicum oleoresin 0.0625 % (capsaicin 0.025 % ) Topical Gel	SY	e2041558-6091-4093-9fc6-44a93df3f0d4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
64058-155-42	64058015542	57 g in 1 BOTTLE	57 g	Historical
64058-155-44	64058015544	113 g in 1 BOTTLE	113 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Miracle ® Plus Overnight Pain Relieving Gel	Concept Laboratories, Inc.	2014-12-03	HUMAN OTC DRUG LABEL	1