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 42 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens AcetaminophenACETAMINOPHENBryant Ranch Prepack190bb2dc-92b4-4b59-a47f-a0251df8261c2025-07-29WarningsExact identifier
application number: M013
Extra Strength NiteTime Pain ReliefACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLETWALGREENSc25c75c7-157f-1c0d-e053-2995a90a2e3c2025-07-25WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.21ab3d58-bb0e-3e51-e063-6294a90ad4152025-07-25WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC3a935584-6045-0a58-e063-6394a90a40c42025-07-23WarningsExact identifier
application number: M013
DR. SANA PAIN AND FEVER FOR ChildrenACETAMINOPHENGADAL Laboratories, Inc8a22a5ba-8623-4cca-8723-52b4954034612025-07-23WarningsExact identifier
application number: M013
DuralginaACETAMINOPHENMenper Distributors Inc.bb31f66c-80a9-4bdb-983b-cef5d21de5ff2025-07-22WarningsExact identifier
application number: M013
GesteiraACETAMINOPHENMenper Distributors, Inc.5a907289-564c-491b-98d5-d7f43eaaa1b22025-07-22WarningsExact identifier
application number: M013
Extra strength Acetaminophen PMACETAMINOPHEN 500MG/ DIPHENHYDRAMINE HCL 25MGTIME CAP LABS INC010c5c98-fc67-a9c3-e063-6394a90aa6402025-07-21WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENMeijer Distribution Inc44d50d79-6e47-429f-8cbe-6fcac46677322025-07-18WarningsExact identifier
application number: M013
ADWE Childrens Pain FeverACETAMINOPHENRARITAN PHARMACEUTICALS INC79a3232f-0211-4c8a-acee-4f87e06ffc262025-07-17WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalmart Inc.24d191ca-a0c4-e1a8-e063-6394a90a7a2a2025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH HEADACHE RELIEFACETAMINOPHEN ASPIRIN CAFFEINEWAL-MART STORES INCd97073cd-b5d7-8c09-e053-2a95a90a89382025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENBETTER LIVING BRANDS LLC.f3005d0c-424e-0ab3-e053-2995a90a1c102025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397fa6e1-37b2-8f51-e063-6394a90a7b942025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc39800c27-f39f-cd60-e063-6394a90acd552025-07-16WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDemoulas Super Markets, Inc397f2b63-733e-5b44-e063-6394a90a97182025-07-16WarningsExact identifier
application number: M013
EXTRA STRENGTH PAIN RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINEBETTER LIVING BRANDS, LLCeb6026d5-d88a-f6b3-e053-2a95a90a5b202025-07-15WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESafewayf9597abc-3f01-4b94-8078-228e0b74677e2025-07-15WarningsExact identifier
application number: M013
Berkley and Jensen Pain ReliefACETAMINOPHENBJWCd3ee3341-93b8-487c-921e-2892d213efbb2025-07-15WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy9e459853-5951-4ae7-88a6-85b502e9dd412025-07-14WarningsExact 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