FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
71399-0160
Requested package NDC
71399-0160-4
11-digit product format
713990160
Labeler code
71399
Product ID
71399-0160_c29d72dc-c7f0-f15b-e053-2995a90a0c79
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
ELIXIR
Route
ORAL
Labeler
Akron Pharma Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-05-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage71399-016071399-0160-4IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
377068df-225f-7318-a910-a1987cdfa361Product name320170608
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-0160-42025-01-30Acetaminophen Elxir Bubble Gum Flavor
71399-0160-62025-01-30Acetaminophen Elxir Bubble Gum Flavor
71399-0160-82025-01-30Acetaminophen Elxir Bubble Gum Flavor
71399-0160-42023-02-10Acetaminophen Elxir Bubble Gum Flavor
71399-0160-82023-02-10Acetaminophen Elxir Bubble Gum Flavor
71399-0160-42023-01-30Acetaminophen Elxir Bubble Gum Flavor
71399-0160-82023-01-30Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0160-4ACETAMINOPHEN118 mL in 1 BOTTLEELIXIR1185
71399-0160-6ACETAMINOPHEN473 mL in 1 BOTTLEELIXIR4735
71399-0160-8ACETAMINOPHEN236 mL in 1 BOTTLEELIXIR2365

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0160-6ML - Milliliter71399-01600aedb9a5-cddb-4bc5-989c-533f4ac4b85a12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-0160ACETAMINOPHEN ELIXIR [AKRON PHARMA INC.]5Legacy NDC, 3 package rows20230211_b31a913a-10e6-49c0-a4c9-de2c0d1ead3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 32 MG/ML Oral SolutionSCDb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 160 MG per 5 ML Oral SolutionSYb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675APAP 32 MG/ML Oral SolutionSYb31a913a-10e6-49c0-a4c9-de2c0d1ead3f5
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 32 MG/ML Oral SolutionSCDed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 32 MG/ML Oral SolutionSCDcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 160 MG per 5 ML Oral SolutionSYed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 160 MG per 5 ML Oral SolutionSYcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYed1583a6-5e10-462b-aba3-5f6137191ab53
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675APAP 32 MG/ML Oral SolutionSYed1583a6-5e10-462b-aba3-5f6137191ab53
307675APAP 32 MG/ML Oral SolutionSYcf2dd95d-afea-462d-9dba-a46a68bf67e63
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 32 MG/ML Oral SolutionSCD57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 160 MG per 5 ML Oral SolutionSY57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675APAP 32 MG/ML Oral SolutionSY57b9b32c-6a5c-49d7-b4df-e0489a98168c2
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675acetaminophen 32 MG/ML Oral SolutionSCDaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675acetaminophen 160 MG per 5 ML Oral SolutionSYaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYaa1c0232-c806-4674-9ac3-6cae7f7499b41
307675APAP 32 MG/ML Oral SolutionSYaa1c0232-c806-4674-9ac3-6cae7f7499b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-0160-471399016004118 mL in 1 BOTTLE (71399-0160-4) 118 ml2021-05-180000-00-00NoNoCurrent