FDA.reportPublic FDA data

TopCare All Day Pain Relief

Product NDC
36800-368
11-digit product format
368000368
Labeler code
36800
Product ID
36800-368_526325f7-8883-4c20-802c-544f75249168
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TopCare All Day 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
36800-368-62TopCare All Day Pain Relief24 in 1 BOTTLETABLET, FILM COATED2411
36800-368-62TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-71TopCare All Day Pain Relief50 in 1 BOTTLETABLET, FILM COATED5011
36800-368-71TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-75TopCare All Day Pain Relief90 in 1 BOTTLETABLET, FILM COATED9011
36800-368-75TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-76TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-76TopCare All Day Pain Relief120 in 1 BOTTLETABLET, FILM COATED12011
36800-368-78TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-78TopCare All Day Pain Relief100 in 1 BOTTLETABLET, FILM COATED10011
36800-368-79TopCare All Day Pain Relief400 in 1 BOTTLETABLET, FILM COATED40011
36800-368-82TopCare All Day Pain Relief1 in 1 CARTONTABLET, FILM COATED111
36800-368-82TopCare All Day Pain Relief200 in 1 BOTTLETABLET, FILM COATED20011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-368-62EA - Each36800-36823e80f87-2467-4f4a-9fd4-697f29bfc9c912012-07-24
36800-368-71EA - Each36800-368c609c5dc-af4a-4860-a698-d5483fffa8e912012-07-24
36800-368-78EA - Each36800-368bcc6e866-be61-4be4-8f4c-d0b1cbd3dd1a12012-07-24
36800-368-82EA - Each36800-368e3bb08cb-edcf-4df2-a057-5df3713f2d0512012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-368TOPCARE ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC]10Current NDC, Legacy NDC, 13 package rows20241001_079eccdd-33bd-4b5c-bf46-9aef78559082.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN079eccdd-33bd-4b5c-bf46-9aef7855908211
849574naproxen sodium 220 MG Oral TabletSCD079eccdd-33bd-4b5c-bf46-9aef7855908211
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY079eccdd-33bd-4b5c-bf46-9aef7855908211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-368-62368000368621 BOTTLE in 1 CARTON (36800-368-62) / 24 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-07-220000-00-00NoNoCurrent
36800-368-71368000368711 BOTTLE in 1 CARTON (36800-368-71) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle1997-01-140000-00-00NoNoCurrent
36800-368-75368000368751 BOTTLE in 1 CARTON (36800-368-75) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-07-120000-00-00NoNoCurrent
36800-368-76368000368761 BOTTLE in 1 CARTON (36800-368-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-06-290000-00-00NoNoCurrent
36800-368-78368000368781 BOTTLE in 1 CARTON (36800-368-78) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2002-06-110000-00-00NoNoCurrent
36800-368-7936800036879400 TABLET, FILM COATED in 1 BOTTLE (36800-368-79) 2019-12-300000-00-00NoNoCurrent
36800-368-82368000368821 BOTTLE in 1 CARTON (36800-368-82) / 200 TABLET, FILM COATED in 1 BOTTLE1 bottle2004-01-270000-00-00NoNoCurrent