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 2026-12-31
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 2026-12-31 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 70 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN, AND CAFFEINE JHK Inc dba American Safety & First Aid 87c5ad71-0448-4e0f-acee-bf9a1d38675e 2024-04-25 Warnings Exact identifier application number: M013 dg health childrens pain and fever ACETAMINOPHEN Dolgencorp Inc 49b2ac72-86a3-4783-bf51-8c1a222e457e 2024-04-25 Warnings Exact identifier application number: M013 basic care infants pain and fever ACETAMINOPHEN Amazon.com Services LLC dab1f9e6-3875-4d53-a417-c6a78274ee56 2024-04-23 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC a71074a6-cc19-4bb3-8c84-4e82a8906801 2024-04-22 Warnings Exact identifier application number: M013 Regular Strength Acetaminophen ACETAMINOPHEN KROGER COMPANY 0fe995cd-f974-db04-e063-6294a90a3355 2024-04-18 Warnings Exact identifier application number: M013 Regular Strength Aspirin 325 mg ASPIRIN Kroger 0fc3193d-af4e-ff3a-e063-6294a90a2743 2024-04-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dye Free ACETAMINOPHEN KROGER COMPANY 0fec66b4-3a2a-63d1-e063-6294a90a6d72 2024-04-17 Warnings Exact identifier application number: M013 aspirin low dose chewable ASPIRIN Time-Cap Labs, Inc 5d56618c-8ea2-42ea-a9f2-339bd0055ddd 2024-04-17 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN P & L Development, LLC 0058175f-3474-40c3-a046-6cfaec86d84b 2024-04-16 Warnings Exact identifier application number: M013 Handy Solutions Headache Pain Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE Navajo Manufacturing Company Inc. e5481abe-6971-2bc5-e053-2995a90ae895 2024-04-15 Warnings Exact identifier application number: M013 childrens acetaminophen ACETAMINOPHEN Major Pharmaceuticals 243a5cff-e506-434b-ab19-1a6ac53f8533 2024-04-15 Warnings Exact identifier application number: M013 Dye Free Pain Reliever Childrens ACETAMINOPHEN P & L Development, LLC 45ddcaad-d416-4d7c-a84a-43548d5c5d3b 2024-04-15 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Navajo Manufacturing Company Inc. 65bf1556-f25a-9439-e053-2a91aa0a3194 2024-04-15 Warnings Exact identifier application number: M013 ACETAMINOPHEN ACETAMINOPHEN Kroger Company bbeebdd6-fe2c-5b8a-e053-2a95a90ab95e 2024-04-13 Warnings Exact identifier application number: M013 infants pain relief ACETAMINOPHEN Publix Super Markets Inc 3d1818a7-d3b2-434c-b3c9-b2713f08ded2 2024-04-13 Warnings Exact identifier application number: M013 Mommys Bliss Childrens Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 08b9eaf7-70d1-640f-e063-6394a90a8d3b 2024-04-12 Warnings Exact identifier application number: M013 Mommys Bliss Infants Pain and Fever ACETAMINOPHEN Mom Enterprises, LLC. 05e26650-81b3-d7b1-e063-6394a90a14ed 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief CHILDRENS PAIN RELIEF Allegiant Health 7381dd26-c507-4d02-b989-cfd96e02f495 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain Relief Dye-Free ACTEAMINOPHEN WinCo Foods, LLC 5ee134b3-b8e9-4621-b0a1-a84d9867ccba 2024-04-11 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN WALGREENS 0b1d086f-7be1-5072-e063-6394a90a11e6 2024-04-10 Warnings Exact identifier application number: M013
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