Aurophen Infants Pain and Fever

Product NDC
58602-206
11-digit product format
586020206
Labeler code
58602
Product ID
58602-206_9cc050c2-e4ee-46a0-a16d-3ff6e7f14e93
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Aurohealth LLC
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-04-30
Marketing end
2022-07-22
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58602-206DDiscontinued by firm2026-10-05
excluded packagepackage58602-20658602-206-07DDiscontinued by firm2026-10-05
excluded packagepackage58602-20658602-206-11DDiscontinued by firm2026-10-05

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-206-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58602-206-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-206-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58602-206-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-206-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58602-206-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-206-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58602-206-07a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-206-11cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58602-206-07cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-206-11cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58602-206-07cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-206-11302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58602-206-07302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-206-11ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58602-206-07ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-206-110efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58602-206-070efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-206-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58602-206-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-206-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58602-206-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-206-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58602-206-07557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8AUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311AUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
CHERRYINACTIVE INGREDIENTBUC5I9595WAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
SORBITOLINACTIVE INGREDIENT506T60A25RAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4AUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEAUROPHEN INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [AUROHEALTH LLC]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-206-07586020206071 BOTTLE in 1 CARTON (58602-206-07) > 30 mL in 1 BOTTLE1 bottle2015-04-302022-07-22NoNoCurrent
58602-206-11586020206111 BOTTLE in 1 CARTON (58602-206-11) > 59 mL in 1 BOTTLE1 bottle2015-04-302022-07-22NoNoCurrent