FDA.reportPublic FDA data

Pain Relief

Product NDC
70677-1120
11-digit product format
706771120
Labeler code
70677
Product ID
70677-1120_24b29584-3cee-525e-e063-6394a90accb4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
STRATEGIC SOURCING SERVICES LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-06-09
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
Pain Relief
Brand name suffix
Extra Strength
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
70677-1120-1Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
70677-1120-1Pain ReliefExtra Strength24 in 1 BOTTLE, PLASTICTABLET, COATED243
70677-1120-2Pain ReliefExtra Strength1 in 1 CARTONTABLET, COATED13
70677-1120-2Pain ReliefExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1120-1EA - Each70677-1120df2f93c9-fbac-4fbd-9151-44b8c9d2e1e512023-09-05
70677-1120-2EA - Each70677-1120cc82e847-0209-41eb-9724-6da601e0767812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1120PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [STRATEGIC SOURCING SERVICES LLC]3Current NDC, 4 package rows20241019_9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e3
198440acetaminophen 500 MG Oral TabletSCD9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e3
198440APAP 500 MG Oral TabletSY9f0aef5d-20b0-469d-a58d-1cbf83a0dd8e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1120-1706771120011 BOTTLE, PLASTIC in 1 CARTON (70677-1120-1) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC2023-06-09NoNoCurrent
70677-1120-2706771120021 BOTTLE, PLASTIC in 1 CARTON (70677-1120-2) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2023-06-09NoNoCurrent