FDA.reportPublic FDA data

Ana-Dent PAIN RELIEF

Product NDC
27854-701
11-digit product format
278540701
Labeler code
27854
Product ID
27854-701_5ac02446-13da-43d5-9647-fe469294acec
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Belmora LLC
Application
ANDA205497
Marketing category
ANDA
Marketing start
2020-05-15
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
Ana-Dent PAIN RELIEF
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
27854-701-01Ana-Dent PAIN RELIEF1 in 1 CARTONTABLET, FILM COATED11
27854-701-01Ana-Dent PAIN RELIEF24 in 1 BOTTLETABLET, FILM COATED241

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-701ANA-DENT PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [BELMORA LLC]1Current NDC, Legacy NDC, 2 package rows20200523_04721306-2850-4e0a-9dd9-7cabb575f3c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN04721306-2850-4e0a-9dd9-7cabb575f3c71
849574naproxen sodium 220 MG Oral TabletSCD04721306-2850-4e0a-9dd9-7cabb575f3c71
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY04721306-2850-4e0a-9dd9-7cabb575f3c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27854-701-01278540701011 BOTTLE in 1 CARTON (27854-701-01) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-05-150000-00-00NoNoCurrent