FDA.reportPublic FDA data

NDC 0149-0033-05 - Dantrium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0149-0033
Requested NDC
0149-0033-05
Package NDCs from labels
0149-0033-05
Manufacturer
Procter & Gamble Pharmaceuticals
Effective date
2006-03-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dantrium - Procter & Gamble PharmaceuticalsProcter & Gamble Pharmaceuticals2006-03-28HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0149-0033-05Dantrium100 in 1 BOTTLECAPSULE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0149-0033DANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]11 package rows20060713_146f7be7-5cd4-4279-a482-794d0cd554e1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dantrolene sodiumACTIVE INGREDIENT287M0347EVDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
dantroleneACTIVE MOIETYF64QU97QCRDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
edible black inkINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
FD&C Yellow No. 6INACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
gelatinINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
lactoseINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
starchINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
synthetic iron oxide redINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
synthetic iron oxide yellowINACTIVE INGREDIENTDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
talcINACTIVE INGREDIENT7SEV7J4R1UDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDANTRIUM (DANTROLENE SODIUM) CAPSULE [PROCTER & GAMBLE PHARMACEUTICALS]1

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 1 of 1 ยท 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DantriumDANTROLENE SODIUMPar Health USA, LLC57b4eec1-49e1-432c-95ae-0fe36e32d64b2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856662
rxcui: 856660
rxcui: 856652
rxcui: 856658
rxcui: 856656
rxcui: 856654
dantrolene sodiumDANTROLENE SODIUMPar Health USA, LLC11689f56-15e0-4350-b53f-ae96e5994fea2026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856660
rxcui: 856652
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMMajor Pharmaceuticals90414d2f-7b2c-47f9-a096-2e7b7dd052de2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMAmneal Pharmaceuticals of New York LLCc3c45b27-f786-456e-95d6-2e38ef36190a2026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856660
rxcui: 856652
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMCardinal Health 107, LLC5ec05285-4cbd-49c4-951b-86829da6f5872025-09-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMAvPAKbd1ef298-2219-2a01-e053-2995a90abb082025-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMAmerican Health Packaging5162f162-8454-4c07-9670-682df7c30b0f2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepacke432a760-40b8-4efa-af2b-18e027ac5ae42024-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856652
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackdbf78d48-71a6-4a9b-bf31-e710b78944f22024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMBryant Ranch Prepackbd218ddb-c133-438c-9545-321ae4b524402024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856660
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackf6ce8871-f1a5-43ea-9250-1999fb69b8352024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackdb715aef-83ca-4608-befa-8288ab4adeea2024-03-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856660
dantrolene sodiumDANTROLENE SODIUMBryant Ranch Prepackc83daa7b-f2c6-418f-a242-fe2d8cad40812023-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856656
Dantrolene SodiumDANTROLENE SODIUMElite Laboratories, Inc.e637fb20-6a17-4522-810a-990bf14097322019-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 856660
rxcui: 856652
rxcui: 856656
146f7be7-5cd4-4279-a482-794d0cd554e1146f7be7-5cd4-4279-a482-794d0cd554e12006-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 146f7be7-5cd4-4279-a482-794d0cd554e1
spl set id: 146f7be7-5cd4-4279-a482-794d0cd554e1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.