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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage82706-00782706-007-04DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage82706-00782706-007-04DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage82706-00782706-007-04DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
e677f43d-b4ce-e5b0-e053-2a95a90ad67eAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PANADOL ExtraACETAMINOPHEN AND CAFFEINEHaleon US Holdings LLCe5c2d88a-d903-4ca0-b895-f27e791dfc4e2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLCb2fe7f47-1a2e-40ee-8f8f-38f2028dce1b2024-02-06WarningsExact identifier
application number: M013
PANADOL Extra StrengthACETAMINOPHENHaleon US Holdings LLC9d384e88-5c11-4600-ac6c-a383715701382024-02-06WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLC95801755-db54-4ad7-bec1-52671914f6ca2024-02-06WarningsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLC01e7dddb-755c-4745-b701-edcdb62090642024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
PANADOL PMACETAMINOPHEN AND DIPHENHYDRAMINE HCLHaleon US Holdings LLCfe7cd1f2-9b00-4ded-99c2-8a152c71093c2024-02-06Warnings, Adverse reactionsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENAptaPharma Inc.9064943f-836f-4853-b6f2-2c4879941eeb2024-02-02WarningsExact identifier
application number: M013
Quality Choice Effervescent Pain ReliefASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.079af5d7-1be8-2a93-e063-6294a90a496d2024-02-01WarningsExact identifier
application number: M013
MEDI-FIRST Non-AspirinACETAMINOPHENProficient Rx LP4c84948d-3a95-4c53-8529-7e7b9d8bb6df2024-02-01WarningsExact identifier
application number: M013
PharbetolACETAMINOPHENProficient Rx LP9c7d65e4-df2f-47c1-a185-66aaf19aad2b2024-02-01WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENProficient Rx LP57e4820c-b4eb-442e-9c49-93eedfbc5e5e2024-02-01WarningsExact identifier
application number: M013
good sense aspirinASPIRINProficient Rx LP73013074-9c6e-43c7-acde-4d9d8ed0133d2024-02-01WarningsExact identifier
application number: M013
MEDIQUE APAP Extra StrengthACETAMINOPHENProficient Rx LPc466a07f-2339-4cf5-8377-e0f109649c522024-02-01WarningsExact identifier
application number: M013
Percogesic Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINEMedtech Products Inc.2c5f1140-fb83-42c9-b0b1-5e2bd69340bb2024-02-01WarningsExact identifier
application number: M013
aspirinASPIRINProficient Rx LP3c7783a7-2b28-4968-b766-0a49dc70ce6d2024-02-01WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.102bdcde-cb90-f248-e063-6394a90aac792024-01-30WarningsExact identifier
application number: M013
Excedrin Extra Strength HeadacheACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINEHaleon US Holdings LLC61802b27-c9ec-4386-9d44-45e8b1e558b72024-01-28WarningsExact identifier
application number: M013
AGRIFENACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLC0fde22da-cdfc-36cc-e063-6294a90a38852024-01-26WarningsExact identifier
application number: M013
DOLODOLACETAMINOPHEN, ASPIRIN, CAFFEINEOPMX LLCe80536f1-92cc-5bb3-e053-2995a90a95402024-01-26WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINBryant Ranch Prepackd913d11f-c7a1-49d2-a2d3-9a29fc0328062024-01-18WarningsExact identifier
application number: M013

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