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 63 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger	3f881349-fcdd-e276-e063-6394a90ae49e	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434cb8b2-a996-5360-e063-6394a90ada03	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	4360e3ec-7a4b-b28e-e063-6294a90a0bd6	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	4360e3be-0ec4-cd57-e063-6394a90aca63	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	43616ad7-58bb-e5ad-e063-6394a90a192b	2025-11-13	Warnings	Exact identifier application number: M017
4x Medicated Severe Toothache and Gum Gel	BENZALKONIUM CHLORIDE	Meijer	97ce7890-5093-1763-e053-2a95a90afae7	2025-11-13	Warnings	Exact identifier application number: M017
Pain Reliever	CAMPHOR, MENTHOL	Kool 'N Fit Inc.	2253f6bd-5707-b993-e063-6394a90aa74a	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	4360e0d1-46cd-ab4b-e063-6394a90a55e1	2025-11-12	Warnings	Exact identifier application number: M017
CVS Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	CVS	8723e097-296f-784a-e053-2991aa0a552e	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154d8821-3e76-b0e2-e063-6294a90ae077	2025-11-12	Warnings	Exact identifier application number: M017
Good neighbor Pharmacy Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	AMERISOURCEBERGEN DRUG CORPORATION	87395273-380c-7cef-e053-2991aa0a54c6	2025-11-12	Warnings	Exact identifier application number: M017
Quality Choice Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Chain Drug Marketing Association	8735b298-83f3-0b5d-e053-2a91aa0a8292	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	1550e794-b3c0-4769-e063-6294a90a8c2d	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154fd46e-f00d-1772-e063-6394a90aba7d	2025-11-12	Warnings	Exact identifier application number: M017
Best Choice Itch Stopping	DIPHENHYDRAMINE HCL	Valu Merchandisers	884cfd64-2cd1-8c12-e053-2995a90a8925	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	CVS	8839149d-e6d5-57cc-e053-2995a90a9832	2025-11-12	Warnings	Exact identifier application number: M017
Itch Stopping	DIPHENHYDRAMINE HCL	Chain Drug Marketing Association	884c9b47-d511-1d17-e053-2995a90a42eb	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 1	BENZOCAINE	Sambria Pharmaceuticals, LLC	2f8fdcac-b87a-4191-9504-480a473f95cc	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 2	LIDOCAINE	Sambria Pharmaceuticals, LLC	180b2899-7699-40e2-974a-081a6ce2bca2	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 3	TETRACAINE	Sambria Pharmaceuticals, LLC	9c24dcff-3988-40eb-821a-fd4b0c85f528	2025-11-12	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