Calypxo Pain Relief

Product NDC: 76420-450
11-digit product format: 764200450
Labeler code: 76420
Product ID: 76420-450_07cec8ef-ecc9-ac49-e063-6294a90a6083
Type: HUMAN OTC DRUG
Nonproprietary name: Methyl Salicylate, Menthol
Dosage form: CREAM
Route: TOPICAL
Labeler: Asclemed USA, Inc
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-01-15
Substance: METHYL SALICYLATE; MENTHOL
Active strength: 10; 3 g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Calypxo Pain Relief
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHYL SALICYLATE	10 g/100g
MENTHOL	3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
LAV5U5022Y	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1486874	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
bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76420-450-12	Calypxo Pain Relief	113 g in 1 BOTTLE	CREAM	113		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-450-12	GM - Gram	76420-450	e387b485-2d49-4f5c-bfa1-3c2fa94acbe0	1	2014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Menthol	ACTIVE INGREDIENT	L7T10EIP3A	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Methyl Salicylate	ACTIVE INGREDIENT	LAV5U5022Y	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Menthol	ACTIVE MOIETY	L7T10EIP3A	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)	INACTIVE INGREDIENT	59TL3WG5CO	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Diazolidinyl Urea	INACTIVE INGREDIENT	H5RIZ3MPW4	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
MethylParaben	INACTIVE INGREDIENT	A2I8C7HI9T	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
PropylParaben	INACTIVE INGREDIENT	Z8IX2SC1OH	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Sodium lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ENOVACHEM MANUFACTURING]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-450	CALYPXO PAIN RELIEF (METHYL SALICYLATE, MENTHOL) CREAM [ASCLEMED USA, INC]	6	Current NDC, Legacy NDC, 1 package rows	20231016_bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6.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 85 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Shopko Hydrocortisone	HYDROCORTISONE	Shopko Stores Operating Co., LLC	92bcbde3-401a-4301-854e-c352852317d6	2025-07-15	Warnings	Exact identifier application number: M017
TopCare Hydrocortisone	HYDROCORTISONE	Topco Associates LLC	bd3585fa-3b48-49b7-8ad1-749bf1e31ed5	2025-07-15	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Pain Relieving	METHYL SALICYLATE	Puretek Corporation	376797ff-cf13-a3c6-e063-6394a90a9de1	2025-07-15	Warnings	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	440e97bc-bd97-4733-9955-643b18e7fb18	2025-07-15	Warnings	Exact identifier application number: M017
Tiger Balm Pain Relieving Hydrogel Large	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	064d04ca-184d-492b-867c-beaa165ab3e0	2025-07-14	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Medcore LLC	143f76bf-2de4-466a-8a6b-d6ab6314a2c3	2025-07-14	Warnings	Exact identifier application number: M017
BLUESPRING Doctors Pain Formula Pain Relief	MENTHOL	ACA MANAGEMENT LLC	98f3f719-792f-4a93-95b1-90072e0f8bf4	2025-07-14	Warnings	Exact identifier application number: M017
Shopko Anti-Itch	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Shopko Stores Operating Co., LLC	130119eb-b87e-4a07-8d2a-317369bfa541	2025-07-14	Warnings	Exact identifier application number: M017
Equate Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Wal-Mart Stores Inc.	635b49c4-54d2-4b6d-bee8-851fc2c7ca9c	2025-07-14	Warnings	Exact identifier application number: M017
ULTRA STRENGTH ZHENG GU SHUI	MENTHOL AND CAMPHOR	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	53397663-044d-4e48-989b-2c6257af5f84	2025-07-14	Warnings, Adverse reactions	Exact identifier application number: M017
TIGER BALM PAIN RELIEVING HYDROGEL	CAMPHOR (SYNTHETIC), LEVOMENTHOL, AND CAPSICUM	Haw Par Healthcare Ltd.	cb60037f-bceb-4090-a5e4-bdda0cbf9f5c	2025-07-14	Warnings	Exact identifier application number: M017
Avedana Hydrocortisone Cream with Aloe	HYDROCORTISONE	Unipack LLC	2a55c426-39b4-4d94-b6b4-6c548c9685e9	2025-07-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Rite Aid Corporation	cb6e0bed-2ea1-49d2-89e7-2554e7565b74	2025-07-11	Warnings	Exact identifier application number: M017
QUALITY CHOICE Maximum Strength Lidocaine Pain Relief Roll On	LIDOCAINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION	7b3ff4c1-0b60-4f7a-8aa4-c84b7c7137c4	2025-07-11	Warnings	Exact identifier application number: M017
Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	TARGET Corporation	6fba5890-f48f-4302-a8ac-5087a6e03bd5	2025-07-11	Warnings	Exact identifier application number: M017
TopCare Antibiotic Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	55dc4025-f07f-41b2-8b18-6a11ee04b5cc	2025-07-11	Warnings	Exact identifier application number: M017
Benadryl Extra Strength Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Kenvue Brands LLC	309d9be0-e367-429a-a1fa-ab7855477c8a	2025-07-10	Warnings	Exact identifier application number: M017
Bengay Vanishing Scent	MENTHOL, UNSPECIFIED FORM	Kenvue Brands LLC	6cc3294b-3b0f-44d0-af71-61db1022d269	2025-07-10	Warnings	Exact identifier application number: M017
Cold Hot Medicated Patch 5% Menthol	MENTHOL	Quality Choice	ce544a7c-8dc6-4e63-b499-d8a4e0ec48c3	2025-07-10	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE ACETATE	Walgreen Company	bff322f1-59c3-41e0-8685-fcfe52bf4b42	2025-07-10	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	PSN	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	6
1486874	menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	6
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	SY	bd9d0bc0-5705-4c73-bcd6-f6cdb68e05b6	6
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	PSN	0b7736df-c7e0-7d00-e063-6294a90aa57e	2
1486874	menthol 30 MG/ML / methyl salicylate 100 MG/ML Topical Cream	SCD	0b7736df-c7e0-7d00-e063-6294a90aa57e	2
1486874	menthol 3 % / methyl salicylate 10 % Topical Cream	SY	0b7736df-c7e0-7d00-e063-6294a90aa57e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-450-12	76420045012	113 g in 1 BOTTLE (76420-450-12)	113 g	2014-01-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Calypxo Cream	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN OTC DRUG LABEL	2
Calypxo Pain Relief - Asclemed USA, Inc	Asclemed USA, Inc	2023-10-16	HUMAN OTC DRUG LABEL	6
CALYPXO CREAM 10% / 3% 4 OZ	DirectRX	2023-07-20	HUMAN OTC DRUG LABEL	2