infants pain and fever

Product NDC: 59779-590
11-digit product format: 597790590
Labeler code: 59779
Product ID: 59779-590_a34699ac-20ae-4ca6-a2c0-20003a0c42e7
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: CVS Pharmacy
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1993-04-30
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 package	package	59779-590	59779-590-10	D	Discontinued by firm		2026-10-21
excluded package	package	59779-590	59779-590-26	D	Discontinued by firm		2026-10-21

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59779-590-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59779-590-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-590-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59779-590-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59779-590-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59779-590-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59779-590-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59779-590-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59779-590-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59779-590-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59779-590-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59779-590-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59779-590-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59779-590-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59779-590-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59779-590-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59779-590-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59779-590-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59779-590-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59779-590-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59779-590-26	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59779-590-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59779-590-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59779-590-26	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: infants pain and fever
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
53b06c48-598e-41ad-ac7a-5508c195535c	Available on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59779-590-10	infants pain and fever	30 mL in 1 BOTTLE	SUSPENSION	30	6
59779-590-10	infants pain and fever	1 in 1 CARTON	SUSPENSION	1	6
59779-590-16	infants pain and fever	1 in 1 CARTON	SUSPENSION	1	6
59779-590-16	infants pain and fever	59 mL in 1 BOTTLE	SUSPENSION	59	6
59779-590-26	infants pain and fever	1 in 1 CARTON	SUSPENSION	1	6
59779-590-26	infants pain and fever	118 mL in 1 BOTTLE	SUSPENSION	118	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59779-590-10	ML - Milliliter	59779-590	b3aefd34-952f-4883-a470-6e51c3f1c3b8	1	2019-12-10
59779-590-16	ML - Milliliter	59779-590	6a643d92-775a-4564-b598-4e0b7309d720	1	2019-12-10
59779-590-26	ML - Milliliter	59779-590	fd201fc1-bf62-47e8-9f31-0d0289d44580	1	2019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
CARRAGEENAN	INACTIVE INGREDIENT	5C69YCD2YJ	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
SODIUM PHOSPHATE, TRIBASIC	INACTIVE INGREDIENT	A752Q30A6X	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59779-590	INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]	6	Current NDC, Legacy NDC, 6 package rows	20240830_53b06c48-598e-41ad-ac7a-5508c195535c.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 71 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	0faa3592-4d56-4645-9a0e-066e0bdfebb6	2024-04-05	Warnings	Exact identifier application number: M013
Pain Relief Childrens Dye Free	ACETAMINOPHEN	H E B	3f9beeeb-5e27-4b81-a647-20e65f0e9fc9	2024-04-03	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	H E B	edb321dd-e5cb-4031-a8a8-efce9e86fe16	2024-04-03	Warnings	Exact identifier application number: M013
Childrens Pain Relief	ACETAMINOPHEN	H E B	a0c0277e-50aa-4328-8f93-ab20c6176b2b	2024-04-03	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	Bryant Ranch Prepack	bda805ab-7f37-405d-a144-4e06ad9a29a1	2024-04-03	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Family Dollar (FAMILY WELLNESS)	650cb15e-c448-4df3-b0f8-4398be05d841	2024-03-27	Warnings	Exact identifier application number: M013
Good Sense Effervescent Pain Relief	ASPIRIN	Perrigo Direct, Inc.	103027a7-2f0e-8d8c-e063-6294a90aedc7	2024-03-26	Warnings	Exact identifier application number: M013
rugby infants acetaminophen	ACETAMINOPHEN	Rugby Laboratories	8aa9ac68-ca61-4163-a876-52034138c1ea	2024-03-25	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	08a18481-f029-f01f-e063-6294a90aac65	2024-03-21	Warnings	Exact identifier application number: M013
Equate Pain Reliever Acetaminophen for Adults 250 mg	ACETAMINOPHEN	Walmart Inc	0d106fa2-2a77-deb2-e063-6394a90a2dac	2024-03-21	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	872c5220-a379-4dc1-b99c-f11ebb82db35	2024-03-19	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	79886972-47a4-44c5-a131-1a691a328103	2024-03-19	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	5ffcc78d-9163-4cb4-8811-ae9f0142806a	2024-03-18	Warnings	Exact identifier application number: M013
ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER	HF Acquisition Co LLC, DBA HealthFirst	13e621dc-b2b4-98fd-e063-6394a90acc75	2024-03-17	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	097a9c98-a092-400d-9600-6797b0b9a50c	2024-03-15	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets and Excedrin Tension Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	978a9d27-6d41-42cb-a193-11314923d2ac	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin PM Triple Action Caplets	ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE	Haleon US Holdings LLC	b3812d27-40af-40d7-864a-dfa4ae34cb9e	2024-03-14	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Pain Reliever	ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE	Haleon US Holdings LLC	691b754c-bafc-47e2-a322-cf56245c01f6	2024-03-14	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	CVS PHARMACY, INC	fdc80b2a-d7c1-4b3d-9a9b-28182c6320de	2024-03-14	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	QUALITY CHOICE (Chain Drug Marketing Association)	2cde052d-22a4-470f-8d6a-7c17061b8ac8	2024-03-14	Warnings	Exact identifier application number: M013

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
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	53b06c48-598e-41ad-ac7a-5508c195535c	6
307668	APAP 32 MG/ML Oral Suspension	SY	53b06c48-598e-41ad-ac7a-5508c195535c	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59779-590-10	59779059010	1 BOTTLE in 1 CARTON (59779-590-10) > 30 mL in 1 BOTTLE	1 bottle	2011-12-07	0000-00-00	No	No	Current
59779-590-16	59779059016	1 BOTTLE in 1 CARTON (59779-590-16) / 59 mL in 1 BOTTLE	1 bottle	2011-12-07	0000-00-00	No	No	Current
59779-590-26	59779059026	1 BOTTLE in 1 CARTON (59779-590-26) > 118 mL in 1 BOTTLE	1 bottle	2018-05-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Pharmacy, Inc. Infants' Pain & Fever Drug Facts	CVS Pharmacy	2026-09-03	HUMAN OTC DRUG LABEL	7