Flex24 Pain Pen

Product NDC: 54641-003
11-digit product format: 546410003
Labeler code: 54641
Product ID: 54641-003_ad288186-8a17-499e-a34c-2b54af419f7a
Type: HUMAN OTC DRUG
Nonproprietary name: camphor
Dosage form: LIQUID
Route: TOPICAL
Labeler: Larasan Pharmaceutical Corporation
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2015-02-10
Marketing end: 0000-00-00
Substance: CAMPHOR (NATURAL)
Active strength: 8 g/100mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54641-003		I	Inactivated by FDA		2026-08-11
excluded package	package	54641-003	54641-003-02	I	Inactivated by FDA		2026-08-11

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 · 38 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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`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	54641-003-02	`8dfbde2a14a4…`	`c9ff85d89658…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54641-003-02	2021-01-29	C162847	48780-1	ba0f9c33-53ae-a910-e053-dadaa90a0b85	4d3dca39-9b4f-4285-85dc-6aac38557f2f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54641-003-02	Flex24 Pain Pen	18 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	18		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54641-003-02	ML - Milliliter	54641-003	a0e20fe6-88ee-4113-9a46-c20f131c73b1	1	2022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CAMPHOR (NATURAL)	ACTIVE INGREDIENT	N20HL7Q941	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
CAMPHOR (NATURAL)	ACTIVE MOIETY	N20HL7Q941	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ACONITUM KUSNEZOFFII ROOT	INACTIVE INGREDIENT	3L29I4K8KX	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ANGELICA DAHURICA ROOT	INACTIVE INGREDIENT	1V63N2S972	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ANGELICA SINENSIS ROOT	INACTIVE INGREDIENT	B66F4574UG	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
DRYNARIA FORTUNEI ROOT	INACTIVE INGREDIENT	731W842X8Q	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ELEUTHEROCOCCUS NODIFLORUS ROOT BARK	INACTIVE INGREDIENT	W7PRK433YB	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
FORSYTHIA SUSPENSA FRUIT	INACTIVE INGREDIENT	P4793M1ES5	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
FRANKINCENSE	INACTIVE INGREDIENT	R9XLF1R1WM	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
GARDENIA JASMINOIDES FRUIT	INACTIVE INGREDIENT	7CTH8MD549	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
LEMON	INACTIVE INGREDIENT	24RS0A988O	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
MYRRH	INACTIVE INGREDIENT	JC71GJ1F3L	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
PAEONIA LACTIFLORA ROOT	INACTIVE INGREDIENT	3Z3866YW6P	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
PAEONIA SUFFRUTICOSA ROOT BARK	INACTIVE INGREDIENT	BUG255FE7X	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
PINELLIA TERNATA ROOT	INACTIVE INGREDIENT	G9AET085M5	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
REHMANNIA GLUTINOSA ROOT	INACTIVE INGREDIENT	1BEM3U6LQQ	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
RHUBARB	INACTIVE INGREDIENT	G280W4MW6E	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
SAFFLOWER	INACTIVE INGREDIENT	4VBL71TY4Y	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
TANGERINE PEEL	INACTIVE INGREDIENT	JU3D414057	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
TURMERIC	INACTIVE INGREDIENT	856YO1Z64F	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ZANTHOXYLUM NITIDUM ROOT	INACTIVE INGREDIENT	L2CQZ81759	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1
ZEDOARY	INACTIVE INGREDIENT	123C43G128	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54641-003	FLEX24 PAIN PEN (CAMPHOR) LIQUID [LARASAN PHARMACEUTICAL CORPORATION]	2	Legacy NDC, 1 package rows	20191210_4d3dca39-9b4f-4285-85dc-6aac38557f2f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1365674	camphor 7.79 % Topical Solution	PSN	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1601550	Flex24 Pain Pen 7.79 % Topical Solution	PSN	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1601550	camphor 0.779 MG/ML Topical Solution [Flex24]	SBD	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1365674	camphor 0.779 MG/ML Topical Solution	SCD	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1365674	camphor 7.79 % Topical Solution	SY	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1601550	Flex24 0.779 MG/ML Topical Solution	SY	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2
1601550	Flex24 7.79 % Pain Pen	SY	4d3dca39-9b4f-4285-85dc-6aac38557f2f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54641-003-02	54641000302	18 mL in 1 BOTTLE, WITH APPLICATOR	18 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
camphor - Larasan Pharmaceutical Corporation \| Dong E E Hua Medical Technology Co Ltd	Larasan Pharmaceutical Corporation \| Dong E E Hua Medical Technology Co Ltd	2019-12-08	HUMAN OTC DRUG LABEL	2