FDA.reportPublic FDA data

Acetaminophen

Product NDC
68094-042
11-digit product format
680940042
Labeler code
68094
Product ID
68094-042_58724859-e9d7-4352-9797-62e2f98b851b
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
2025-01-13
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
5a68ab98-720c-479a-a60a-4e594add6c09Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-042-01Acetaminophen2.5 mL in 1 SYRINGE, PLASTICSUSPENSION2.51
68094-042-58Acetaminophen10 in 1 BAGSUSPENSION101
68094-042-58Acetaminophen5 in 1 CASESUSPENSION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-042-01ML - Milliliter68094-0427ec21617-9121-4b43-b3d5-d0fee46ed4ea12025-03-04
68094-042-58ML - Milliliter68094-042bc1fd5c0-9342-47e5-9e24-a2f46f04d77b12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-042ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.]1Current NDC, 3 package rows20250113_5a68ab98-720c-479a-a60a-4e594add6c09.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 40 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENP & L Development, LLC64c642b7-ef83-44b7-a014-6fa248dff3ba2025-09-08WarningsExact identifier
application number: M013
Extra Strength Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINEBJWC (Berkley & Jensen / BJ's)2f473f1f-7cf3-2af5-e063-6394a90aaa172025-09-01WarningsExact identifier
application number: M013
foster and thrive rapid release pain reliefACETAMINOPHENStrategic Sourcing Services LLCd2130173-b107-4ae6-a1f7-6db467da38202025-08-30WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.e1d4f562-433c-4344-9b77-1a7c731d1be52025-08-29WarningsExact identifier
application number: M013
Aspirin Enteric Coated Low DoseASPIRINWalgreen Companyb11a4c4e-374c-403e-a757-5e9700f9f03b2025-08-27WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENSafeway0e0a73f9-8c18-41fd-812e-8be20287e77a2025-08-26WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINBJWC (Berkley & Jensen / BJ's)577035a5-88ab-431c-8598-7a19dd633fe92025-08-26WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENSixarp, LLC2e20be17-2b6c-1a07-e063-6394a90acdd32025-08-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINBJWC (Berkley & Jensen / BJ's)2f32b096-d29a-c7c7-e063-6294a90a2bbe2025-08-22WarningsExact identifier
application number: M013
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPublix Super Markets Inc6b691dc1-09e4-46d3-b199-8917e42848a62025-08-19WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENP & L Development, LLC59eb14a5-40b0-4331-beb5-7166e6cdf4112025-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmacaf5daea-409e-5dd2-e053-2995a90acb122025-08-18WarningsExact identifier
application number: M013
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
application number: M013
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
application number: M013
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
application number: M013
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5a68ab98-720c-479a-a60a-4e594add6c091
307668acetaminophen 32 MG/ML Oral SuspensionSCD5a68ab98-720c-479a-a60a-4e594add6c091
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5a68ab98-720c-479a-a60a-4e594add6c091
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5a68ab98-720c-479a-a60a-4e594add6c091
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5a68ab98-720c-479a-a60a-4e594add6c091
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5a68ab98-720c-479a-a60a-4e594add6c091
307668APAP 32 MG/ML Oral SuspensionSY5a68ab98-720c-479a-a60a-4e594add6c091

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-042-01680940042012.5 mL in 1 SYRINGE, PLASTIC2.5 mlHistorical
68094-042-58680940042585 BAG in 1 CASE (68094-042-58) / 10 SYRINGE, PLASTIC in 1 BAG / 2.5 mL in 1 SYRINGE, PLASTIC (68094-042-01) 5 bag2025-01-13NoNoCurrent