ULTRA THERAPY PAIN RELIEF

Product NDC
55628-1001
Requested package NDC
55628-1001-2
11-digit product format
556281001
Labeler code
55628
Product ID
55628-1001_d8ec90bf-0259-49ab-8a4c-27ec4d34613b
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, METHYL SALICYLATE, CAPSAICIN
Dosage form
LOTION
Route
TOPICAL
Labeler
Cal Pharma
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-11-29
Marketing end
0000-00-00
Substance
MENTHOL; METHYL SALICYLATE; CAPSAICIN
Active strength
10 g/100mL; g/100mL; 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55628-100155628-1001-2DDiscontinued by firm2026-08-03

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 · 16 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55628-1001-22024-03-28C16284748780-1d6a99b39-b98a-a426-e053-dadaa90af4c23d42ba94-0a53-4cc2-bda4-a4284c28c974
55628-1001-22022-01-28C16284748780-1d6a99b39-b98a-a426-e053-dadaa90af4c23d42ba94-0a53-4cc2-bda4-a4284c28c974

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
MENTHOLACTIVE INGREDIENTL7T10EIP3AULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022YULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
CAPSAICINACTIVE MOIETYS07O44R1ZMULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
MENTHOLACTIVE MOIETYL7T10EIP3AULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
GAULTHERIA PROCUMBENS LEAFINACTIVE INGREDIENT2125M16OWNULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
GLUCOSAMINE HYDROCHLORIDEINACTIVE INGREDIENT750W5330FYULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4ULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
MARITIME PINEINACTIVE INGREDIENT50JZ5Z98QYULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
PETASITES HYBRIDUS LEAFINACTIVE INGREDIENTJOS311ZC1GULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
WATERINACTIVE INGREDIENT059QF0KO0RULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
WILLOW BARKINACTIVE INGREDIENTS883J9JDYXULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
ZANTHOXYLUM AMERICANUM BARKINACTIVE INGREDIENTA4KL1HMZ7TULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10
ZANTHOXYLUM BUNGEANUM WHOLEINACTIVE INGREDIENTWH9894JM8KULTRA THERAPY PAIN RELIEF (MENTHOL, METHYL SALICYLATE, CAPSAICIN) LOTION [CAL PHARMA]10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55628-1001-255628100102120 mL in 1 TUBE (55628-1001-2) 120 ml2012-11-290000-00-00NoNoCurrent