Home NDC 53145-052 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 2027-12-31
Current FDA listing Yes 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 53145-052-04 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 53145-052-04 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 53145-052-04 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 Gesteira
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 675 mg/15mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2719840 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53145-052-04 Gesteira 1 in 1 CARTON LIQUID 1 4 53145-052-04 Gesteira 120 mL in 1 BOTTLE LIQUID 120 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 CITRIC ACID ACETATE INACTIVE INGREDIENT DSO12WL7AU GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GESTEIRA (ACETAMINOPHEN) LIQUID [MENPER DISTRIBUTORS, INC.] 1
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 69 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53145-052-04 53145005204 1 BOTTLE in 1 CARTON (53145-052-04) / 120 mL in 1 BOTTLE 1 bottle 2012-02-21 0000-00-00 No No Current