Pain Relief 8 HR

Product NDC
37808-747
11-digit product format
378080747
Labeler code
37808
Product ID
37808-747_6b75a346-403e-45e1-a74d-21c0b8dcd8ed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
H E B
Application
ANDA075077
Marketing category
ANDA
Marketing start
2017-02-24
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pain Relief 8 HR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-747-71Pain Relief 8 HR50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE505
37808-747-71Pain Relief 8 HR1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-747PAIN RELIEF 8 HR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [H E B]5Current NDC, Legacy NDC, 2 package rows20221113_b5c7e93b-e626-49c3-a7d4-773475f945ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNb5c7e93b-e626-49c3-a7d4-773475f945ae5
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDb5c7e93b-e626-49c3-a7d4-773475f945ae5
11483998 HR APAP 650 MG Extended Release Oral TabletSYb5c7e93b-e626-49c3-a7d4-773475f945ae5
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYb5c7e93b-e626-49c3-a7d4-773475f945ae5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-747-71378080747711 BOTTLE in 1 CARTON (37808-747-71) / 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2017-02-240000-00-00NoNoCurrent