FDA.reportPublic FDA data

First Aid Direct All Day Pain Relief

Product NDC
42961-122
11-digit product format
429610122
Labeler code
42961
Product ID
42961-122_dc86ba45-5462-4c1b-9a65-4bcf25e0e43b
Type
HUMAN OTC DRUG
Nonproprietary name
Naproxen Sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cintas Corporation
Application
ANDA204872
Marketing category
ANDA
Marketing start
2023-07-19
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
First Aid Direct 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
42961-122-01First Aid Direct All Day Pain Relief1 in 1 PACKETTABLET, COATED13
42961-122-02First Aid Direct All Day Pain Relief25 in 1 BOXTABLET, COATED253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42961-122FIRST AID DIRECT ALL DAY PAIN RELIEF (NAPROXEN SODIUM) TABLET, COATED [CINTAS CORPORATION]2Current NDC, 2 package rows20241226_1c9384c1-52f8-4482-88fc-5f5b6d770c42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
849574naproxen sodium 220 MG Oral TabletPSN1c9384c1-52f8-4482-88fc-5f5b6d770c423
849574naproxen sodium 220 MG Oral TabletSCD1c9384c1-52f8-4482-88fc-5f5b6d770c423
849574naproxen sodium 220 MG (as naproxen 200 MG) Oral TabletSY1c9384c1-52f8-4482-88fc-5f5b6d770c423

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42961-122-01429610122011 in 1 PACKETHistorical
42961-122-024296101220225 PACKET in 1 BOX (42961-122-02) / 1 TABLET, COATED in 1 PACKET (42961-122-01) 25 packet2023-07-19NoNoHistorical