FDA.reportPublic FDA data

Acetaminophen

Product NDC
68094-030
11-digit product format
680940030
Labeler code
68094
Product ID
68094-030_969e07e8-8e42-47bc-a77b-0ff7893d3175
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-06
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Acetaminophen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

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
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1d4f562-433c-4344-9b77-1a7c731d1be5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-030-59Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESUSPENSION20.314
68094-030-62Acetaminophen10 in 1 TRAYSUSPENSION1014
68094-030-62Acetaminophen3 in 1 CASESUSPENSION314
68094-030-59Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESUSPENSION20.38
68094-030-62Acetaminophen10 in 1 TRAYSUSPENSION108
68094-030-62Acetaminophen3 in 1 CASESUSPENSION38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-030-59ML - Milliliter68094-0304f106025-d725-47cb-b077-92ffbe43768212019-10-07
68094-030-62ML - Milliliter68094-030d7f1105a-e030-4de4-8800-3f2f533d5c3712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-030ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]8Current NDC, Legacy NDC, 3 package rows20250302_d3d32de6-9272-43c9-9b31-bd1f45c55a8d.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 30 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bayer Rapid ReliefASPIRIN/CAFFEINE ORAL POWDERBayer HealthCare LLC.f1fecbb0-5b55-fe8f-e053-2995a90a09772025-12-05WarningsExact identifier
application number: M013
Headache Relief, Extra Strength 24/7 Life by 7-ElevenACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET, FILM COATEDLil' Drug Store Products, Inc.45381b1c-2acd-1524-e063-6394a90a83d92025-12-05WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENUnited Natural Foods, Inc. dba UNFI729132cd-f209-447a-8949-a90b5a5c01da2025-12-05WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp05fda811-d65f-41b2-89e4-297cdddb3d992025-12-05WarningsExact identifier
application number: M013
aspirinASPIRINHealth Pharma USA, LLC3165b0a3-556b-6abe-e063-6394a90a76822025-12-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINBayer HealthCare LLC.44a08904-68b9-4d06-a28d-21aae3d6140c2025-12-04WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp7a29dde6-a177-6206-e053-2991aa0a01f22025-12-04WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENGeri-Care Pharmaceutical Corp7570aaa2-3238-4cd3-b788-915caa970dba2025-12-04WarningsExact identifier
application number: M013
Bayer HeadacheASPIRIN AND CAFFEINEBayer HealthCare LLC.c0a92873-0914-6a86-e053-2995a90ac41c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorALKA-SELTZER ORIGINAL FLAVORBayer HealthCare LLC.07478020-5ba0-3b67-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Severe Sinus Cold and Cough Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.0dba1329-5b0d-5688-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer Plus Cold Medicine Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.78537dcf-b157-4b67-a8b2-5cb1448151662025-12-04WarningsExact identifier
application number: M013
BAYER Aspirin Extra Strength CapletsBAYER ASPIRIN EXTRA STRENGTHBayer HealthCare LLC.0ae64cdb-4ea0-23af-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry FlavoredASPIRINBayer HealthCare LLC.070d5713-e018-2913-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M013
Bayer Low DoseASPIRINBayer HealthCare LLC.075b103e-0bb4-4b7a-ac0e-5645bcbd0a072025-12-04WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
application number: M013
Bayer Aspirin Regimen enteric coatedASPIRINBayer HealthCare LLC.0c6ae05f-7634-34d1-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M013
aspirin pain reliefASPIRINRite Aid Corporationae9d9977-7576-4894-8a32-454828abec9a2025-12-04WarningsExact identifier
application number: M013
ASPIRINASPIRINRMT HEALTH LLC2bacffd1-4870-73af-e063-6294a90a19c82025-12-02WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINERite Aid Corporationd9caee45-be43-45ec-927f-e7fec5c14f072025-12-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 32 MG/ML Oral SuspensionSCDe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668APAP 32 MG/ML Oral SuspensionSYe1d4f562-433c-4344-9b77-1a7c731d1be514
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668acetaminophen 32 MG/ML Oral SuspensionSCDd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYd3d32de6-9272-43c9-9b31-bd1f45c55a8d8
307668APAP 32 MG/ML Oral SuspensionSYd3d32de6-9272-43c9-9b31-bd1f45c55a8d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-030-596809400305920.3 mL in 1 CUP, UNIT-DOSE20.3 mlHistorical
68094-030-62680940030623 TRAY in 1 CASE (68094-030-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (68094-030-59) 3 tray2019-09-060000-00-00NoNoCurrent