FDA.reportPublic FDA data

Good Sense Pain and Fever

Product NDC
68788-8646
11-digit product format
687888646
Labeler code
68788
Product ID
68788-8646_181ef7a2-b4ad-4406-a040-07bd3a6ea73e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part343
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-24
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Good Sense 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
7dbd0a2d-8597-4010-bfe2-94a8d145ca57Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8646-1Good Sense Pain and Fever118 mL in 1 BOTTLESUSPENSION1183
68788-8646-1Good Sense Pain and Fever1 in 1 CARTONSUSPENSION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8646-1ML - Milliliter68788-864642033f79-b93c-4cec-8187-9f714222af1412024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8646GOOD SENSE PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250228_7dbd0a2d-8597-4010-bfe2-94a8d145ca57.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
ndc (product): 68788-8646

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668acetaminophen 32 MG/ML Oral SuspensionSCD7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7dbd0a2d-8597-4010-bfe2-94a8d145ca573
307668APAP 32 MG/ML Oral SuspensionSY7dbd0a2d-8597-4010-bfe2-94a8d145ca573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8646-1687888646011 BOTTLE in 1 CARTON (68788-8646-1) / 118 mL in 1 BOTTLE1 bottle2024-04-24NoNoCurrent