FDA.reportPublic FDA data

equate pain and fever

Product NDC
49035-946
11-digit product format
490350946
Labeler code
49035
Product ID
49035-946_dbaf8d52-5060-4d2e-8b1f-663ca06cb847
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Wal-Mart Stores Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-08
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equate pain and fever
Brand name suffix
infants
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui307668

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-946-10equate pain and feverinfants30 mL in 1 BOTTLESUSPENSION306
49035-946-10equate pain and feverinfants1 in 1 CARTONSUSPENSION16
49035-946-16equate pain and feverinfants1 in 1 CARTONSUSPENSION16
49035-946-16equate pain and feverinfants59 mL in 1 BOTTLESUSPENSION596

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-946-10ML - Milliliter49035-9460b63dd65-e435-48b2-a06f-39e72bd246d512013-02-13
49035-946-16ML - Milliliter49035-9460456c2f1-54cb-495c-8ad2-a56d16c93c2d12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SODIUM PHOSPHATE, TRIBASICINACTIVE INGREDIENTA752Q30A6XEQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
SORBITOLINACTIVE INGREDIENT506T60A25REQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3
WATERINACTIVE INGREDIENT059QF0KO0REQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-946EQUATE PAIN AND FEVER INFANTS (ACETAMINOPHEN) SUSPENSION [WAL-MART STORES INC]6Current NDC, Legacy NDC, 4 package rows20240719_8a152c8d-8ae0-4201-8bb9-7b22c3577415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 32 MG/ML Oral SuspensionSCD8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156
307668APAP 32 MG/ML Oral SuspensionSY8a152c8d-8ae0-4201-8bb9-7b22c35774156

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-946-10490350946101 BOTTLE in 1 CARTON (49035-946-10) > 30 mL in 1 BOTTLE1 bottle2011-09-140000-00-00NoNoCurrent
49035-946-16490350946161 BOTTLE in 1 CARTON (49035-946-16) / 59 mL in 1 BOTTLE1 bottle2011-08-080000-00-00NoNoCurrent