FDA.reportPublic FDA data

Childrens Pain and Fever

Product NDC
73282-2164
Requested package NDC
73282-2164-1
11-digit product format
732822164
Labeler code
73282
Product ID
73282-2164_e8a64fa3-66d6-18b8-e053-2995a90ae4f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 160mg/5mL
Dosage form
SOLUTION
Route
ORAL
Labeler
CalmCo LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-09-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage73282-216473282-2164-1IInactivated by FDA2026-10-05

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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73282-2164-12024-07-30C16284748780-11e7a6dab-16b3-a2ce-e063-dadaa90aadf7DrKids Children's Pain and Fever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73282-2164-1Childrens Pain and Fever4 in 1 VIAL, SINGLE-DOSESOLUTION43
73282-2164-1Childrens Pain and Fever5 mL in 1 VIAL, SINGLE-DOSESOLUTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73282-2164CHILDRENS PAIN AND FEVER (ACETAMINOPHEN 160MG/5ML) SOLUTION [CALMCO LLC]3Legacy NDC, 2 package rows20230725_e8a64fa3-66d5-18b8-e053-2995a90ae4f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675acetaminophen 32 MG/ML Oral SolutionSCDe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675acetaminophen 160 MG per 5 ML Oral SolutionSYe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYe8a64fa3-66d5-18b8-e053-2995a90ae4f63
307675APAP 32 MG/ML Oral SolutionSYe8a64fa3-66d5-18b8-e053-2995a90ae4f63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
73282-2164-1732822164014 VIAL, SINGLE-DOSE in 1 VIAL, SINGLE-DOSE (73282-2164-1) > 5 mL in 1 VIAL, SINGLE-DOSE2022-09-010000-00-00NoNoCurrent