FDA.reportPublic FDA data

Rugby All Day Relief

Product NDC
0536-1093
11-digit product format
005361093
Labeler code
0536
Product ID
0536-1093_56300998-5c48-4f1c-83d2-747011fa7de6
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rugby Laboratories
Application
ANDA074661
Marketing category
ANDA
Marketing start
2015-09-02
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
Rugby All Day 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
0536-1093-01Rugby All Day Relief100 in 1 BOTTLETABLET, FILM COATED1007
0536-1093-01Rugby All Day Relief1 in 1 CARTONTABLET, FILM COATED17
0536-1093-06Rugby All Day Relief1 in 1 CARTONTABLET, FILM COATED17
0536-1093-06Rugby All Day Relief50 in 1 BOTTLETABLET, FILM COATED507
0536-1093-11Rugby All Day Relief1 in 1 CARTONTABLET, FILM COATED17
0536-1093-11Rugby All Day Relief90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1093-01EA - Each0536-1093247336fa-dd5d-4ef9-b7fc-56cf938f84c412015-11-12
0536-1093-06EA - Each0536-109323cc3549-a913-4856-b1f5-32cb01d1633312015-10-02
0536-1093-11EA - Each0536-1093cf3d3389-4524-461c-b9be-ac7dba12d26512022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
NAPROXENACTIVE MOIETY57Y76R9ATQRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61URUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WORUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30RUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ARUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ERUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1093RUGBY ALL DAY RELIEF (NAPROXEN SODIUM) TABLET, FILM COATED [RUGBY LABORATORIES]5Current NDC, Legacy NDC, 6 package rows20220319_16e107f0-45a3-428f-b849-0f20a848a602.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN16e107f0-45a3-428f-b849-0f20a848a6027
849574naproxen sodium 220 MG Oral TabletSCD16e107f0-45a3-428f-b849-0f20a848a6027
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY16e107f0-45a3-428f-b849-0f20a848a6027
849574naproxen sodium 220 MG Oral TabletPSN3238dfdc-82d1-4afb-b27c-0ba0a5d247441
849574naproxen sodium 220 MG Oral TabletSCD3238dfdc-82d1-4afb-b27c-0ba0a5d247441
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY3238dfdc-82d1-4afb-b27c-0ba0a5d247441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1093-01005361093011 BOTTLE in 1 CARTON (0536-1093-01) > 100 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-020000-00-00NoNoCurrent
0536-1093-06005361093061 BOTTLE in 1 CARTON (0536-1093-06) / 50 TABLET, FILM COATED in 1 BOTTLE1 bottle2015-09-150000-00-00NoNoCurrent
0536-1093-11005361093111 BOTTLE in 1 CARTON (0536-1093-11) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-03-180000-00-00NoNoCurrent