Infants Pain Relief

Product NDC
68016-160
11-digit product format
680160160
Labeler code
68016
Product ID
68016-160_991bcb88-e32d-43c9-86f9-2a9c8af5ed6a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Chain Drug Consortium (Premier Value)
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-10-03
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
E
Listing certified through
2017-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-160IInactivated by FDA2026-10-05
excluded packagepackage68016-16068016-160-02IInactivated by FDA2026-10-05

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-160-02IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-160-02IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-160-02IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-160-02IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-160-02IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-160-02IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-160-02IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-160-02IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-160-02IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-160-02IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-160-02IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-160-02IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68016-160-02IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68016-160-02IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68016-160-02IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-160-02IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-160-02IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-160-02IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68016-160-02IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68016-160-02IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68016-160-02IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68016-160-02EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-160-022020-01-31C16284748780-19d75b9cf-e2c7-f424-e053-dadaa90a57ceInfant's Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-160-02Infants Pain Relief1 in 1 CARTONLIQUID11
68016-160-02Infants Pain Relief59 mL in 1 BOTTLE, PLASTICLIQUID591

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-160-02ML - Milliliter68016-160f71b6fee-7f54-478e-9b58-84c5970e883012014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
AcetaminophenACTIVE MOIETY362O9ITL9DINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
CarboxymethylcelluloseINACTIVE INGREDIENT05JZI7B19XINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
High Fructose Corn syrupINACTIVE INGREDIENTXY6UN3QB6SINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
Polyethylene Glycol 1450INACTIVE INGREDIENTOJ4Z5Z32L4INFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3INFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
SorbitolINACTIVE INGREDIENT506T60A25RINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
SucraloseINACTIVE INGREDIENT96K6UQ3ZD4INFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
WaterINACTIVE INGREDIENT059QF0KO0RINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEINFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-160INFANTS PAIN RELIEF (ACETAMINOPHEN) LIQUID [CHAIN DRUG CONSORTIUM (PREMIER VALUE)]1Legacy NDC, 2 package rows20141112_60476951-a730-4ee6-b270-2f4ac868cfe0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN60476951-a730-4ee6-b270-2f4ac868cfe01
307668acetaminophen 32 MG/ML Oral SuspensionSCD60476951-a730-4ee6-b270-2f4ac868cfe01
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY60476951-a730-4ee6-b270-2f4ac868cfe01
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY60476951-a730-4ee6-b270-2f4ac868cfe01
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY60476951-a730-4ee6-b270-2f4ac868cfe01
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY60476951-a730-4ee6-b270-2f4ac868cfe01
307668APAP 32 MG/ML Oral SuspensionSY60476951-a730-4ee6-b270-2f4ac868cfe01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-160-02680160160021 in 1 CARTONHistorical