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 106 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydrocortisone	HYDROCORTISONE 1%	Pharmacy Value Alliance LLC	ab95e606-69f0-1d58-e053-2a95a90a073b	2024-12-20	Warnings	Exact identifier application number: M017
Itch Relief Cream	ZINC ACETATE 0.1%, DIPHENHYDRAMINE HYDROCHLORIDE 2%	Pharmacy Value Alliance LLC	37fe6d82-adee-4f58-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M017
Warrior First Aid Anti Itch	DIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	ec6e9a5b-c61d-a385-e053-2995a90ac936	2024-12-20	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE HCL	Derma Care Research Labs, LLC	ff227154-cf3b-9796-e053-6294a90a5535	2024-12-20	Warnings	Exact identifier application number: M017
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE HCL 4%	Meijer	f31b11ed-2ff9-5cfc-e053-2a95a90af2ca	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier application number: M017
Mirakel Pain and Itch Relief	BENZOCAINE 20%, RESORCINOL 3%	Sanvio, Inc.	ed34d728-0275-e209-e053-2995a90a93ff	2024-12-20	Warnings	Exact identifier application number: M017
Meijer Pain Relief	LIDOCAINE 4%	Meijer	bed67c31-c479-6f9b-e053-2a95a90a5516	2024-12-20	Warnings	Exact identifier application number: M017
Blue-Emu Ultra with Hemp Seed	TROLAMINE SALICYLATE	Kingsway Pharmaceuticals dba NFI, LLC	80a3cf99-16e8-412b-ab9f-3d9d5cbb7aa9	2024-12-20	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e4d9bc32-ac85-349f-e053-2995a90a032f	2024-12-19	Warnings	Exact identifier application number: M017
Epsom Salts	MAGNESIUM SULFATE	International Wholesale Inc.	e5f3edc2-1b79-533a-e053-2a95a90ae9b6	2024-12-19	Warnings	Exact identifier application number: M017
Leader	LIDOCAINE HCL	Cardinal Health	cea6bd2d-a265-1209-e053-2995a90ab0a5	2024-12-19	Warnings	Exact identifier application number: M017
Rugby Anti-Itch	CAMPHOR, MENTHOL	RUGBY LABORATORIES	99d8ad9e-46ec-15fc-e053-2995a90a0d17	2024-12-19	Warnings	Exact identifier application number: M017
DCH Calaspray Itch Relief	PRAMOXINE HCL 1%, ZINC ACETATE 0.1%	Derma Care Research Labs, LLC	fda2afaf-3cd0-92b3-e053-6394a90a7493	2024-12-19	Warnings	Exact identifier application number: M017
DCH Nerve Pain Relief Roll-On	LIDOCAINE HCL 4%, MENTHOL 1%	Derma Care Research Labs, LLC	ff32cbb2-79eb-9158-e053-6394a90ac357	2024-12-19	Warnings	Exact identifier application number: M017
DCH Burn Relief	LIDOCAINE, 0.5%	Derma Care Research Labs	ffd7be08-0510-dfcb-e053-6394a90ad286	2024-12-19	Warnings	Exact identifier application number: M017
DCH Arthritis Pain Relief Roll-On	CAPSAISIN 0.1%	Derma Care Research Labs, LLC	fda0d359-95eb-8b38-e053-6294a90a7b88	2024-12-19	Warnings	Exact identifier application number: M017
DCH Pain Relieving	MENTHOL 2%	Derma Care Research Labs, LLC	ff49ee63-6a87-c7a7-e053-6294a90a77a3	2024-12-19	Warnings	Exact identifier application number: M017
Warrior Pain Relief Roll-On Maximum Strength	LIDOCAINE HCL 4%	Derma Care Research Labs, LLC	dd80e560-6467-2166-e053-2995a90a88a8	2024-12-19	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