FDA.reportPublic FDA data

Topcare All Day Pain Relief

Product NDC
36800-490
11-digit product format
368000490
Labeler code
36800
Product ID
36800-490_07c1ea6c-a75e-4600-b44b-4e1562fde80b
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
1997-01-14
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 All Day Pain Relief
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
36800-490-62Topcare All Day Pain Relief24 in 1 BOTTLETABLET, FILM COATED2410
36800-490-62Topcare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-490-71Topcare All Day Pain Relief50 in 1 BOTTLETABLET, FILM COATED5010
36800-490-71Topcare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-490-75Topcare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-490-75Topcare All Day Pain Relief90 in 1 BOTTLETABLET, FILM COATED9010
36800-490-76Topcare All Day Pain Relief120 in 1 BOTTLETABLET, FILM COATED12010
36800-490-76Topcare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-490-78Topcare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED110
36800-490-78Topcare All Day Pain Relief100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-490-62EA - Each36800-4904dce1bc0-469a-430c-b55d-a4ad078b0ecc12012-07-24
36800-490-71EA - Each36800-490381c2714-0ccf-4002-b1e1-f7c05df1683012012-07-24
36800-490-78EA - Each36800-490b6efa084-be29-439a-973d-d01439ee8fc012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
NAPROXENACTIVE MOIETY57Y76R9ATQTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ETOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [TOPCO ASSOCIATES LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-490TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]9Current NDC, Legacy NDC, 10 package rows20250202_7f1cda40-9a67-4de1-af56-ab881c6354c4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN7f1cda40-9a67-4de1-af56-ab881c6354c410
849574naproxen sodium 220 MG Oral TabletSCD7f1cda40-9a67-4de1-af56-ab881c6354c410
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY7f1cda40-9a67-4de1-af56-ab881c6354c410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-490-62368000490621 BOTTLE in 1 CARTON (36800-490-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-07-220000-00-00NoNoCurrent
36800-490-71368000490711 BOTTLE in 1 CARTON (36800-490-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-01-140000-00-00NoNoCurrent
36800-490-75368000490751 BOTTLE in 1 CARTON (36800-490-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-12-090000-00-00NoNoCurrent
36800-490-76368000490761 BOTTLE in 1 CARTON (36800-490-76) > 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2009-04-070000-00-00NoNoCurrent
36800-490-78368000490781 BOTTLE in 1 CARTON (36800-490-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2002-06-110000-00-00NoNoCurrent