ACETAMINOPHEN

Product NDC: 71399-0160
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71399-0160		I	Inactivated by FDA	2026-10-05
excluded package	package	71399-0160	71399-0160-4	I	Inactivated by FDA	2026-10-05
excluded package	package	71399-0160	71399-0160-6	I	Inactivated by FDA	2026-10-05
excluded package	package	71399-0160	71399-0160-8	I	Inactivated by FDA	2026-10-05

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71399-0160-4	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71399-0160-6	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71399-0160-8	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71399-0160-4	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71399-0160-6	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71399-0160-8	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71399-0160-4	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71399-0160-6	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71399-0160-8	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71399-0160-4	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71399-0160-6	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71399-0160-8	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71399-0160-4	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71399-0160-6	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71399-0160-8	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71399-0160-4	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71399-0160-6	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71399-0160-8	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71399-0160-4	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71399-0160-8	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71399-0160-6	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71399-0160-4	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71399-0160-8	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71399-0160-6	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71399-0160-4	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71399-0160-8	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71399-0160-6	U	Excluded because listing certification expired	`0efc9e666f02…`	`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 concept	Relation	Version	Effective
75d4bef7-334c-4a95-abb5-bff9def24114	Product name	2	20260112
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7f	Product name	5	20250115
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
88300afc-e1c4-ad17-c80b-4957f1b809a5	Product name	5	20250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043	Product name	7	20240611
16cde546-8deb-4df2-a072-dab5566ede95	Product name	1	20231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66f	Product name	1	20230808
a3631b20-02d1-41d7-8187-5e5e850b9e80	Product name	1	20230306
79e1734e-f721-4d46-978a-be382f771672	Product name	2	20230110
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6	Product name	9	20220921
92ead9ae-674d-4eee-a492-c385d496891f	Product name	3	20220308
103b151b-b17f-42ac-8624-3ef62f5e2975	Product name	2	20200507
b8497372-efe9-9dde-fa2d-59be9761aa64	Product name	9	20200428
20c8cafe-5cfc-44f8-a9be-a664f437f780	Product name	2	20200225
3a16d77a-e865-468a-aedf-6e58913c1c21	Product name	3	20190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880	Product name	1	20190320
00d531e4-b130-8c52-eaf9-826cbb6f15dd	Product name	3	20190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659	Product name	9	20190205
22d922aa-c443-d9f3-b23c-03b03a9ad31c	Product name	7	20181220
377068df-225f-7318-a910-a1987cdfa361	Product name	3	20170608
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
23475c0b-a5b5-4fec-b97f-acca901eae6a	Product name	1	20140718
105ef617-6fa4-6713-326f-72ec8a6b75a9	Product name	1	20140508
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
3ed6b849-48b8-8899-c288-6eeb396123b6	Product name	1	20140508
47fd879b-91c5-e1e5-130f-29d082a871ec	Product name	1	20140508
53855190-7124-8179-f018-e792f7c27f28	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0	Product name	1	20140508
96c5169b-5b9d-547d-bf22-d688d91866e4	Product name	1	20140508
b8e0daf1-fb81-290b-c0bf-873be19ef775	Product name	1	20140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00	Product name	1	20140508
c8753a88-edde-8e17-a396-705537b52cee	Product name	1	20140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ce	Product name	1	20140508
cf3a804d-0326-aa22-0142-c184b5657d85	Product name	1	20140508
d83c592c-dd97-4cbf-36ac-13da806684bd	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71399-0160-4	2025-01-30	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-6	2025-01-30	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2025-01-30	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-4	2023-02-10	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2023-02-10	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-4	2023-01-30	Acetaminophen Elxir Bubble Gum Flavor
71399-0160-8	2023-01-30	Acetaminophen Elxir Bubble Gum Flavor

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71399-0160-4	ACETAMINOPHEN	118 mL in 1 BOTTLE	ELIXIR	118	5
71399-0160-6	ACETAMINOPHEN	473 mL in 1 BOTTLE	ELIXIR	473	5
71399-0160-8	ACETAMINOPHEN	236 mL in 1 BOTTLE	ELIXIR	236	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-0160-6	ML - Milliliter	71399-0160	0aedb9a5-cddb-4bc5-989c-533f4ac4b85a	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-0160	ACETAMINOPHEN ELIXIR [AKRON PHARMA INC.]	5	Legacy NDC, 3 package rows	20230211_b31a913a-10e6-49c0-a4c9-de2c0d1ead3f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 32 MG/ML Oral Solution	SCD	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	APAP 32 MG/ML Oral Solution	SY	b31a913a-10e6-49c0-a4c9-de2c0d1ead3f	5
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 32 MG/ML Oral Solution	SCD	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 32 MG/ML Oral Solution	SCD	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	APAP 32 MG/ML Oral Solution	SY	ed1583a6-5e10-462b-aba3-5f6137191ab5	3
307675	APAP 32 MG/ML Oral Solution	SY	cf2dd95d-afea-462d-9dba-a46a68bf67e6	3
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 32 MG/ML Oral Solution	SCD	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	APAP 32 MG/ML Oral Solution	SY	57b9b32c-6a5c-49d7-b4df-e0489a98168c	2
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 32 MG/ML Oral Solution	SCD	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1
307675	APAP 32 MG/ML Oral Solution	SY	aa1c0232-c806-4674-9ac3-6cae7f7499b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71399-0160-4	71399016004	118 mL in 1 BOTTLE (71399-0160-4)	118 ml	2019-10-25	0000-00-00	No	No	Current
71399-0160-6	71399016006	473 mL in 1 BOTTLE	473 ml					Historical
71399-0160-8	71399016008	236 mL in 1 BOTTLE (71399-0160-8)	236 ml	2019-10-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP \| UNIT DOSE SOLUTIONS	2023-03-13	HUMAN OTC DRUG LABEL	2
Acetaminophen Elxir Bubble Gum Flavor	Akron Pharma Inc.	2023-02-04	HUMAN OTC DRUG LABEL	5
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-11-14	HUMAN OTC DRUG LABEL	3
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-11-03	HUMAN OTC DRUG LABEL	3
Acetaminophen Elxir Bubble Gum Flavor	ATLANTIC BIOLOGICALS CORP. \| UNIT DOSE SOLUTIONS	2022-10-25	HUMAN OTC DRUG LABEL	1