Childrens Pain and Fever

Product NDC: 73282-2164
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	73282-2164		I	Inactivated by FDA		2026-10-05
excluded package	package	73282-2164	73282-2164-1	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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73282-2164-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73282-2164-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73282-2164-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73282-2164-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73282-2164-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73282-2164-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73282-2164-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73282-2164-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73282-2164-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73282-2164-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	73282-2164-1	`367a005e9d99…`	`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
NDC	Effective	Action	Document	Indexing SPL	Related label
73282-2164-1	2024-07-30	C162847	48780-1	1e7a6dab-16b3-a2ce-e063-dadaa90aadf7	DrKids Children's Pain and Fever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73282-2164-1	Childrens Pain and Fever	4 in 1 VIAL, SINGLE-DOSE	SOLUTION	4		3
73282-2164-1	Childrens Pain and Fever	5 mL in 1 VIAL, SINGLE-DOSE	SOLUTION	5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73282-2164	CHILDRENS PAIN AND FEVER (ACETAMINOPHEN 160MG/5ML) SOLUTION [CALMCO LLC]	3	Legacy NDC, 2 package rows	20230725_e8a64fa3-66d5-18b8-e053-2995a90ae4f6.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	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	acetaminophen 32 MG/ML Oral Solution	SCD	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3
307675	APAP 32 MG/ML Oral Solution	SY	e8a64fa3-66d5-18b8-e053-2995a90ae4f6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
73282-2164-1	73282216401	4 VIAL, SINGLE-DOSE in 1 VIAL, SINGLE-DOSE (73282-2164-1) > 5 mL in 1 VIAL, SINGLE-DOSE	2022-09-01	0000-00-00	No	No	Current