FDA.reportPublic FDA data

All Day Pain Relief

Product NDC
37808-068
11-digit product format
378080068
Labeler code
37808
Product ID
37808-068_cc1eb980-a014-48df-83cd-9cfa050b4414
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
ANDA079096
Marketing category
ANDA
Marketing start
2015-09-30
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-068-242021-04-28C16284748780-1ba0f9c33-2114-a910-e053-dadaa90a0b85Drug Facts
37808-068-502021-04-28C16284748780-1ba0f9c33-2114-a910-e053-dadaa90a0b85Drug Facts
37808-068-242021-01-29C16284748780-1ba0f9c33-2114-a910-e053-dadaa90a0b85Drug Facts
37808-068-502021-01-29C16284748780-1ba0f9c33-2114-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-068-24All Day Pain Relief24 in 1 BOTTLE, PLASTICTABLET2410
37808-068-24All Day Pain Relief1 in 1 BOXTABLET110
37808-068-50All Day Pain Relief1 in 1 BOXTABLET110
37808-068-50All Day Pain Relief50 in 1 BOTTLE, PLASTICTABLET5010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
NAPROXENACTIVE MOIETY57Y76R9ATQALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
TALCINACTIVE INGREDIENT7SEV7J4R1UALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-068ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET [H E B]10Current NDC, Legacy NDC, 4 package rows20231220_6dd54a14-67cd-4295-9bd5-1d6f8cb9316d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN6dd54a14-67cd-4295-9bd5-1d6f8cb9316d10
849574naproxen sodium 220 MG Oral TabletSCD6dd54a14-67cd-4295-9bd5-1d6f8cb9316d10
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY6dd54a14-67cd-4295-9bd5-1d6f8cb9316d10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-068-24378080068241 BOTTLE, PLASTIC in 1 BOX (37808-068-24) / 24 TABLET in 1 BOTTLE, PLASTIC2015-09-300000-00-00NoNoCurrent
37808-068-50378080068501 BOTTLE, PLASTIC in 1 BOX (37808-068-50) / 50 TABLET in 1 BOTTLE, PLASTIC2015-09-300000-00-00NoNoCurrent