FDA.reportPublic FDA data

Gesteira

Product NDC
53145-052
11-digit product format
531450052
Labeler code
53145
Product ID
53145-052_3a89ea39-3fbe-7bc0-e063-6294a90aed2d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
Menper Distributors, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-02-21
Substance
ACETAMINOPHEN
Active strength
675 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gesteira
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN675 mg/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui2719840

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-052-042023-07-28C16284748780-19d75b9d0-ff37-f424-e053-dadaa90a57ceGesteira
53145-052-042021-08-11C16284748780-19d75b9d0-ff37-f424-e053-dadaa90a57ceGesteira
53145-052-042020-01-31C16284748780-19d75b9d0-ff37-f424-e053-dadaa90a57ceGesteira

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-052-04Gesteira1 in 1 CARTONLIQUID14
53145-052-04Gesteira120 mL in 1 BOTTLELIQUID1204

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719840acetaminophen 675 MG in 15 mL Oral SolutionPSN5a907289-564c-491b-98d5-d7f43eaaa1b24
2719840acetaminophen 45 MG/ML Oral SolutionSCD5a907289-564c-491b-98d5-d7f43eaaa1b24
2719840acetaminophen 675 MG per 15 mL Oral SolutionSY5a907289-564c-491b-98d5-d7f43eaaa1b24
2719840APAP 45 MG/ML Oral SolutionSY5a907289-564c-491b-98d5-d7f43eaaa1b24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-052-04531450052041 BOTTLE in 1 CARTON (53145-052-04) / 120 mL in 1 BOTTLE1 bottle2012-02-210000-00-00NoNoCurrent