FDA.reportPublic FDA data

NOTTS - Extra Strength 500 mg

Product NDC
82706-007
11-digit product format
827060007
Labeler code
82706
Product ID
82706-007_2df54d96-b18b-e9e3-e063-6294a90a6926
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
VIVUNT PHARMA LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-17
Substance
ACETAMINOPHEN
Active strength
500 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
NOTTS - Extra Strength 500 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui198440

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82706-007-01NOTTS - Extra Strength 500 mg1 in 1 CARTONTABLET112
82706-007-01NOTTS - Extra Strength 500 mg24 in 1 BOTTLE, PLASTICTABLET2412
82706-007-02NOTTS - Extra Strength 500 mg100 in 1 BOTTLE, PLASTICTABLET10012
82706-007-02NOTTS - Extra Strength 500 mg1 in 1 CARTONTABLET112
82706-007-03NOTTS - Extra Strength 500 mg400 in 1 BOTTLE, PLASTICTABLET40012
82706-007-04NOTTS - Extra Strength 500 mg2 in 1 POUCHTABLET212
82706-007-04NOTTS - Extra Strength 500 mg3 in 1 CARTONTABLET312
82706-007-05NOTTS - Extra Strength 500 mg2 in 1 POUCHTABLET212
82706-007-05NOTTS - Extra Strength 500 mg50 in 1 CARTONTABLET5012
82706-007-06NOTTS - Extra Strength 500 mg25 in 1 CARTONTABLET2512
82706-007-06NOTTS - Extra Strength 500 mg25 in 1 BLISTER PACKTABLET2512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82706-007NOTTS - EXTRA STRENGTH 500 MG (ACETAMINOPHEN) TABLET [VIVUNT PHARMA LLC]12Current NDC, Legacy NDC, 11 package rows20250215_e677f43d-b4ce-e5b0-e053-2a95a90ad67e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNe677f43d-b4ce-e5b0-e053-2a95a90ad67e12
198440acetaminophen 500 MG Oral TabletSCDe677f43d-b4ce-e5b0-e053-2a95a90ad67e12
198440APAP 500 MG Oral TabletSYe677f43d-b4ce-e5b0-e053-2a95a90ad67e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82706-007-01827060007011 BOTTLE, PLASTIC in 1 CARTON (82706-007-01) / 24 TABLET in 1 BOTTLE, PLASTIC2022-08-170000-00-00NoNoCurrent
82706-007-02827060007021 BOTTLE, PLASTIC in 1 CARTON (82706-007-02) / 100 TABLET in 1 BOTTLE, PLASTIC2022-08-170000-00-00NoNoCurrent
82706-007-0382706000703400 TABLET in 1 BOTTLE, PLASTIC (82706-007-03) 400 tablet2022-08-170000-00-00NoNoCurrent
82706-007-04827060007043 POUCH in 1 CARTON (82706-007-04) / 2 TABLET in 1 POUCH3 pouch2023-09-20NoNoCurrent
82706-007-058270600070550 POUCH in 1 CARTON (82706-007-05) / 2 TABLET in 1 POUCH50 pouch2024-07-05NoNoCurrent
82706-007-068270600070625 BLISTER PACK in 1 CARTON (82706-007-06) / 25 TABLET in 1 BLISTER PACK25 blister pack2025-02-12NoNoCurrent