Dye Free Childrens Acetaminophen

Product NDC
68094-061
11-digit product format
680940061
Labeler code
68094
Product ID
68094-061_046ba40e-c1d0-4bdf-b8c9-fc46c1a6ed19
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
2022-08-02
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
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 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68094-061-62ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68094-061-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68094-061-620efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68094-061-610efc9e666f02…f202fb6c5f17…

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
Dye Free Childrens 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
5cc698fa-0841-4851-ae21-0aac8b40eb0aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-061-59Dye Free Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION54
68094-061-61Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION104
68094-061-61Dye Free Childrens Acetaminophen10 in 1 CASESUSPENSION104
68094-061-62Dye Free Childrens Acetaminophen3 in 1 CASESUSPENSION34
68094-061-62Dye Free Childrens Acetaminophen10 in 1 TRAYSUSPENSION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-061-59ML - Milliliter68094-0617ffde884-046e-4467-bf19-e6963019ceeb12022-09-12
68094-061-61ML - Milliliter68094-06101f444ad-976b-4dee-a6d8-58370a3ce67612022-09-12
68094-061-62ML - Milliliter68094-06196850414-3946-419e-af60-8205fe94744c12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-061DYE FREE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]4Current NDC, Legacy NDC, 5 package rows20250122_5cc698fa-0841-4851-ae21-0aac8b40eb0a.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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 32 MG/ML Oral SuspensionSCD5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4
307668APAP 32 MG/ML Oral SuspensionSY5cc698fa-0841-4851-ae21-0aac8b40eb0a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-061-59680940061595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-061-616809400616110 TRAY in 1 CASE (68094-061-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59) 10 tray2022-08-020000-00-00NoNoCurrent
68094-061-62680940061623 TRAY in 1 CASE (68094-061-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59) 3 tray2022-08-020000-00-00NoNoCurrent