FDA.reportPublic FDA data

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59779-59059779-590-10DDiscontinued by firm2026-10-21
excluded packagepackage59779-59059779-590-26DDiscontinued by firm2026-10-21

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 datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0559779-590-26d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0559779-590-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2659779-590-26f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2659779-590-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3159779-590-262ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3159779-590-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2859779-590-26a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2859779-590-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2159779-590-26cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2159779-590-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1059779-590-26cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1059779-590-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3159779-590-26302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3159779-590-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2059779-590-26ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2059779-590-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1059779-590-260efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1059779-590-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0859779-590-26ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0859779-590-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0359779-590-26367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0359779-590-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0959779-590-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0959779-590-26557ba5c1ecfa…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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53b06c48-598e-41ad-ac7a-5508c195535cAvailable on FDA.report

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-590-10infants pain and fever30 mL in 1 BOTTLESUSPENSION306
59779-590-10infants pain and fever1 in 1 CARTONSUSPENSION16
59779-590-16infants pain and fever1 in 1 CARTONSUSPENSION16
59779-590-16infants pain and fever59 mL in 1 BOTTLESUSPENSION596
59779-590-26infants pain and fever1 in 1 CARTONSUSPENSION16
59779-590-26infants pain and fever118 mL in 1 BOTTLESUSPENSION1186

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-590-10ML - Milliliter59779-590b3aefd34-952f-4883-a470-6e51c3f1c3b812019-12-10
59779-590-16ML - Milliliter59779-5906a643d92-775a-4564-b598-4e0b7309d72012019-12-10
59779-590-26ML - Milliliter59779-590fd201fc1-bf62-47e8-9f31-0d0289d4458012019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
SORBITOLINACTIVE INGREDIENT506T60A25RINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4INFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2
WATERINACTIVE INGREDIENT059QF0KO0RINFANTS PAIN AND FEVER (ACETAMINOPHEN) LIQUID [CVS PHARMACY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-590INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY]6Current NDC, Legacy NDC, 6 package rows20240830_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 75 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-SeltzerBUFFERED ASPIRINLil' Drug Store Products, Inc.0c7a60e7-0bde-9aa2-e063-6294a90a32092023-12-14WarningsExact identifier
application number: M013
Circle K Aspirin 325ASPIRINLil Drug Store Products, Inc4cd306e3-2119-4272-9da4-a848fe2746fa2023-12-14WarningsExact identifier
application number: M013
Circle K Pain Reliever Extra StrengthACETAMINOPHENLil' Drug Store Products, Inc.f2359bc3-901f-4ecb-b402-cb2fe404a9352023-12-14WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MARTc55b8f9d-1396-43c0-acc9-5e3485eadb072023-12-08WarningsExact identifier
application number: M013
Childrens Pain ReliefACETAMINOPHENDISCOUNT DRUG MART775519ad-5683-451f-9bfc-5fafc70c68ec2023-12-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.c20c814b-35f5-4c46-e053-2a95a90a50f22023-12-08WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENBetter Living Brands LLCf9859be4-6d0b-2ab8-e053-6294a90aa8622023-12-06WarningsExact identifier
application number: M013
Aurophen Regular StrengthACETAMINOPHENKROGER COMPANYb9b7b849-c3b3-9af7-e053-2a95a90a00772023-12-06WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENKROGER COMPANYcf649478-57d2-cc88-e053-2a95a90ad1ba2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENKROGER COMPANYb9b6f878-1ec8-3dc0-e053-2995a90a54142023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.a48c522c-76c5-49f8-8c4d-3ee6b221e6f32023-12-06WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREEN CO.cc939a7c-ce56-5dd6-e053-2995a90aa8af2023-12-06WarningsExact identifier
application number: M013
Alka-Seltzer Original FlavorBUFFERED ASPIRIN, EFFERVESCENT TABLETLil' Drug Store Products, Inc.ea5df8be-a08c-5fa3-e053-2995a90a0bac2023-12-06WarningsExact identifier
application number: M013
RinglACETAMINOPHENSato Pharmaceutical Co., Ltd.ba5a0286-3e0f-4bef-96e5-29d92f51f4322023-12-06WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)41633554-474e-4d3c-9187-d90487d2ae8c2023-12-06WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFamily Dollar Stores, LLCf86dcbb8-debc-4bce-e053-6294a90a7a022023-12-05WarningsExact identifier
application number: M013
Sanatos Multi Symptom DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRPharmadel LLC0a5fc0ef-ba34-bb0b-e063-6394a90af7d92023-12-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProficient Rx LP402c8563-b14b-453f-80bc-4275f1c737022023-12-01WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAurohealth LLC3ba51b52-7ae6-4335-b178-1b7b6ef362272023-11-29WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENAurohealth LLCbc03fa56-8880-4bbd-81a0-91853fecdd4e2023-11-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN53b06c48-598e-41ad-ac7a-5508c195535c6
307668acetaminophen 32 MG/ML Oral SuspensionSCD53b06c48-598e-41ad-ac7a-5508c195535c6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY53b06c48-598e-41ad-ac7a-5508c195535c6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY53b06c48-598e-41ad-ac7a-5508c195535c6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY53b06c48-598e-41ad-ac7a-5508c195535c6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY53b06c48-598e-41ad-ac7a-5508c195535c6
307668APAP 32 MG/ML Oral SuspensionSY53b06c48-598e-41ad-ac7a-5508c195535c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59779-590-10597790590101 BOTTLE in 1 CARTON (59779-590-10) > 30 mL in 1 BOTTLE1 bottle2011-12-070000-00-00NoNoCurrent
59779-590-16597790590161 BOTTLE in 1 CARTON (59779-590-16) / 59 mL in 1 BOTTLE1 bottle2011-12-070000-00-00NoNoCurrent
59779-590-26597790590261 BOTTLE in 1 CARTON (59779-590-26) > 118 mL in 1 BOTTLE1 bottle2018-05-290000-00-00NoNoCurrent