Celadrin

Product NDC: 54230-356
11-digit product format: 542300356
Labeler code: 54230
Product ID: 54230-356_097fcff2-ea99-0878-e063-6394a90aa0fd
Type: HUMAN OTC DRUG
Nonproprietary name: Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Factors Group of Nutritional Products
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-10-01
Substance: MENTHOL
Active strength: 12.5 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54230-356-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54230-356-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54230-356-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54230-356-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54230-356-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54230-356-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54230-356-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Celadrin
Brand name suffix: Joint and Muscle Pain Relieving
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	12.5 mg/g

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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
416982	Internal RxNorm lookup
1046429	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6396e4b6-2130-433b-bdb3-97c76dbe685c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54230-356-01	2023-03-30	C162847	48780-1	9d75b9d1-1749-f424-e053-dadaa90a57ce	Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)
54230-356-01	2020-01-31	C162847	48780-1	9d75b9d1-1749-f424-e053-dadaa90a57ce	Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54230-356-01	CeladrinJoint and Muscle Pain Relieving	170 g in 1 JAR	CREAM	170		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
Menthol	ACTIVE MOIETY	L7T10EIP3A	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
BENZYL ALCOHOL	INACTIVE INGREDIENT	LKG8494WBH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54230-356	CELADRIN JOINT AND MUSCLE PAIN RELIEVING (MENTHOL) CREAM [FACTORS GROUP OF NUTRITIONAL PRODUCTS]	3	Current NDC, Legacy NDC, 1 package rows	20231107_6396e4b6-2130-433b-bdb3-97c76dbe685c.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 119 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BENGAY Tropical Jasmine	LIDOCAINE	Kenvue Brands LLC	c416320a-c0d7-401e-b0fa-44114d76a557	2024-11-06	Warnings	Exact identifier application number: M017
Bengay Ultra Strength Large Size	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	f57ccc33-400b-4401-a348-c54d1eb9f5d0	2024-11-06	Warnings	Exact identifier application number: M017
Band Aid Antiseptic Cleansing To Go	BENZALKONIUM CHLORIDE, PRAMOXINE HCL	Kenvue Brands LLC	d5749cba-32f3-cf9c-e053-2a95a90a4416	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	26473383-282c-fb10-e063-6394a90a5fa2	2024-11-06	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	GOLDEN TIGER DISTRIBUTION L.L.C.	1b6f929a-db65-8a02-e063-6394a90a8b59	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	bd6f04f9-a23b-45f6-bce2-1ef7203198e1	2024-11-06	Warnings	Exact identifier application number: M017
Meijer Cold and Hot Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	6d356563-9098-4994-8ad8-819a8033a9f4	2024-11-06	Warnings	Exact identifier application number: M017
TopCare Maximum Strength Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM	Topco Associates LLC	dc80d2f9-e3eb-4feb-bad5-7d6ab107f9ab	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Restorative Skin Therapy Itch Relief Balm	PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	61824ca7-a2d3-4830-b2bb-149a3222bfc8	2024-11-05	Warnings	Exact identifier application number: M017
Aveeno Hydrocortisone ANTI-ITCH	HYDROCORTISONE	Kenvue Brands LLC	233de4d7-e533-40cd-a5ed-e8b09abc626e	2024-11-05	Warnings	Exact identifier application number: M017
STING MASTER	LIDOCAINE HYDROCHLORIDE	Les Technologies Ptero, Inc	94c6fd1f-9e74-420b-9d25-61b37953b838	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	0c8e65a6-dff3-43b4-a3f1-95deb574ea89	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35ac19-6883-a733-e063-6294a90ad22d	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Plus	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products, Inc.	cfe8114b-df65-064b-e053-2a95a90a33f6	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Botanicals	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	02a8e5c7-56f4-eb0d-e063-6294a90a80cd	2024-11-05	Warnings	Exact identifier application number: M017
Alocane Emergency Burn Pads	LIDOCAINE HYDROCHLORIDE	Quest Products, Inc.	fe58bb89-7216-4121-afd3-d1438bdfbfa2	2024-11-05	Warnings	Exact identifier application number: M017
Licefreee AfterLice	PRAMOXINE HCI	Tec Laboratories Inc.	06c4cc42-a215-3949-e063-6394a90a665e	2024-11-05	Warnings	Exact identifier application number: M017
Antibacterial Lidocaine Wound Gel	BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE	ASO LLC	cb9505b7-222d-3a24-e053-2a95a90a0b64	2024-11-05	Warnings	Exact identifier application number: M017
TopCare Pain Relieving Analgesic	LIDOCAINE HYDROCHLORIDE	Topco Associates LLC	6b4783e0-1987-4838-9e8c-b95426d62b28	2024-11-05	Warnings	Exact identifier application number: M017
Eagle Green Balm	CAMPHOR MENTHOL	Borden Company (Private) Limited	6f7a796b-a31c-0e60-e053-2a91aa0a022b	2024-11-04	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046429	Celadrin 1.25 % Topical Cream	PSN	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 1.25 % Topical Cream	PSN	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	menthol 12.5 MG/ML Topical Cream [Celadrin]	SBD	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 12.5 MG/ML Topical Cream	SCD	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin 1.25 % Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin 12.5 MG/ML Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
1046429	Celadrin Cream 12.5 MG/ML Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3
416982	menthol 1.25 % Topical Cream	SY	6396e4b6-2130-433b-bdb3-97c76dbe685c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
54230-356-01	54230035601	170 g in 1 JAR (54230-356-01)	170 g	2012-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Factors Group (as PLD) - Celadrin Joint and Muscle Pain Relieving Cream (54230-356)	Factors Group of Nutritional Products	2023-11-06	HUMAN OTC DRUG LABEL	3