FDA.reportPublic FDA data

CALMADOL PAIN RELIEVER

Product NDC
48201-007
11-digit product format
482010007
Labeler code
48201
Product ID
48201-007_4240708f-eaa2-9c13-e063-6294a90ab632
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
GRANDALL DISTRIBUTING, LLC
Application
ANDA090545
Marketing category
ANDA
Marketing start
2015-03-31
Substance
NAPROXEN SODIUM
Active strength
220 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CALMADOL PAIN RELIEVER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NAPROXEN SODIUM220 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9TN87S3A3C
Rxcui849574

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fef6ad89-235f-4274-ba49-a8e53642473eProduct name220250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ffProduct name320230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8Product name120200623
e76dbbc1-775d-722c-08ff-ed45e8a80defProduct name320181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7cProduct name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48201-007-24CALMADOL PAIN RELIEVER1 in 1 BOXTABLET17
48201-007-24CALMADOL PAIN RELIEVER24 in 1 PACKETTABLET247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-007CALMADOL PAIN RELIEVER (NAPROXEN SODIUM) TABLET [GRANDALL DISTRIBUTING, LLC]6Current NDC, Legacy NDC, 2 package rows20240124_8edec8d1-a323-436b-8329-c327438516e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN8edec8d1-a323-436b-8329-c327438516e37
849574naproxen sodium 220 MG Oral TabletSCD8edec8d1-a323-436b-8329-c327438516e37
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY8edec8d1-a323-436b-8329-c327438516e37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48201-007-24482010007241 PACKET in 1 BOX (48201-007-24) / 24 TABLET in 1 PACKET1 packet2015-03-310000-00-00NoNoCurrent