FDA.reportPublic FDA data

Acetaminophen

Product NDC
0121-2823
11-digit product format
001212823
Labeler code
0121
Product ID
0121-2823_bbd6f65a-a6ec-4c17-935c-ed743c45e2c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-03
Substance
ACETAMINOPHEN
Active strength
650 mg/20.3mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/20.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-2823-21Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESUSPENSION20.35
0121-2823-94Acetaminophen10 in 1 TRAYSUSPENSION105
0121-2823-94Acetaminophen3 in 1 CASESUSPENSION35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-2823-21ML - Milliliter0121-2823718f60b6-0027-4acc-9dfd-b7d15553ffbb12022-01-06
0121-2823-94ML - Milliliter0121-2823fcc3545e-3a08-4bc7-a690-dfb8483128be12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-2823ACETAMINOPHEN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]4Current NDC, Legacy NDC, 3 package rows20241114_caf5daea-409e-5dd2-e053-2995a90acb12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 32 MG/ML Oral SuspensionSCDcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668APAP 32 MG/ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-2823-210012128232120.3 mL in 1 CUP, UNIT-DOSE20.3 mlHistorical
0121-2823-94001212823943 TRAY in 1 CASE (0121-2823-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-2823-21) 3 tray2021-09-030000-00-00NoNoCurrent