FDA.reportPublic FDA data

topcare back and muscle pain

Product NDC
36800-696
11-digit product format
368000696
Labeler code
36800
Product ID
36800-696_e1367ee6-554f-4e94-ba77-ec9c86f2ecd2
Type
HUMAN OTC DRUG
Nonproprietary name
naproxen sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates LLC
Application
ANDA074661
Marketing category
ANDA
Marketing start
2019-06-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
topcare back and muscle pain
Listing expiration
2027-12-31

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
36800-696-75topcare back and muscle pain90 in 1 BOTTLETABLET, FILM COATED905
36800-696-75topcare back and muscle pain1 in 1 CARTONTABLET, FILM COATED15
36800-696-78topcare back and muscle pain1 in 1 CARTONTABLET, FILM COATED15
36800-696-78topcare back and muscle pain100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-696TOPCARE BACK AND MUSCLE PAIN (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]4Current NDC, Legacy NDC, 4 package rows20250130_de587e8f-38f2-4e7a-8e6a-64e48f280c4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSNde587e8f-38f2-4e7a-8e6a-64e48f280c4f5
849574naproxen sodium 220 MG Oral TabletSCDde587e8f-38f2-4e7a-8e6a-64e48f280c4f5
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSYde587e8f-38f2-4e7a-8e6a-64e48f280c4f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-696-75368000696751 BOTTLE in 1 CARTON (36800-696-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-130000-00-00NoNoCurrent
36800-696-78368000696781 BOTTLE in 1 CARTON (36800-696-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2019-06-250000-00-00NoNoCurrent