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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5a907289-564c-491b-98d5-d7f43eaaa1b2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53145-052-04	2023-07-28	C162847	48780-1	9d75b9d0-ff37-f424-e053-dadaa90a57ce	Gesteira
53145-052-04	2021-08-11	C162847	48780-1	9d75b9d0-ff37-f424-e053-dadaa90a57ce	Gesteira
53145-052-04	2020-01-31	C162847	48780-1	9d75b9d0-ff37-f424-e053-dadaa90a57ce	Gesteira

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
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 55 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ACETAMINOPHEN (RED)	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd	a352f588-4a70-42b2-8f9c-a73a0629517d	2024-11-25	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	5c42dd28-820c-4cc5-9016-11ad5e580616	2024-11-25	Warnings	Exact identifier application number: M013
equate pain reliever	ACETAMINOPHEN	WALMART INC.	4518fe82-3ba8-4e9e-a036-776df7fb8d57	2024-11-21	Warnings	Exact identifier application number: M013
Family Wellness Pain Reliever	ASPIRIN	FAMILY WELLNESS SERVICES, INC.	075e19f4-1a58-aedd-e063-6294a90af708	2024-11-20	Warnings	Exact identifier application number: M013
Mejoralito	ACETAMINOPHEN	OPMX Chula Vista	fd2ecde0-296e-060f-e053-6294a90afd98	2024-11-15	Warnings	Exact identifier application number: M013
Temp X	ACETAMINOPHEN	OPMX Chula Vista	fd2edc32-0351-c991-e053-6294a90ab4ce	2024-11-15	Warnings	Exact identifier application number: M013
CVS Health Extra Strength Antacid and Pain Reliever	ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE	CVS Pharmacy	afe9e755-18ba-305f-e053-2995a90aa8d0	2024-11-14	Warnings	Exact identifier application number: M013
Walgreens Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Walgreens	667418fc-a3ab-cbc7-e053-2a91aa0a2023	2024-11-13	Warnings	Exact identifier application number: M013
Up and Up Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Target Corporation	a72eef45-b985-638a-e053-2995a90aa20a	2024-11-13	Warnings	Exact identifier application number: M013
Signature Care Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Safeway, Inc	6e120024-475a-73af-e053-2a91aa0a42a6	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Kroger Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Kroger Company	6d858b0e-a3c8-2686-e053-2991aa0acc06	2024-11-13	Warnings	Exact identifier application number: M013
TopCare Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Topco Associates LLC	639f9d57-f26a-708a-e053-2a91aa0a6962	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	H. E. Butt Grocery Company	6418cde9-607b-4ca1-e053-2991aa0a9170	2024-11-13	Warnings	Exact identifier application number: M013
Bromo Seltzer	ASPIRIN, SODIUM BICARBONATE, CITRIC ACID	Tower Laboratories Ltd	8ff88ee1-e33e-4051-992f-24e2720c48ce	2024-11-13	Warnings	Exact identifier application number: M013
Care One Original Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Foodhold U.S.A.	8f662c51-d2fa-6458-e053-2995a90ac6fd	2024-11-13	Warnings	Exact identifier application number: M013
Top Value Effervescent Pain Relief	APIRIN, CITRIC ACID, SODIUM BICARBONATE	Tower Laboratories Ltd	43c7f435-735c-3fab-e054-00144ff88e88	2024-11-13	Warnings, Adverse reactions	Exact identifier application number: M013
DG Health Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	DOLGENCORP, INC	8f1343d5-2884-3a14-e053-2a95a90a2f90	2024-11-13	Warnings	Exact identifier application number: M013
Good Sense Effervescent Antacid and Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Good Sense	cd25b0c3-0134-beef-e053-2a95a90a092b	2024-11-13	Warnings	Exact identifier application number: M013
Drug Mart Effervescent Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Discount Drug Mart, Inc	8bc65603-1dbf-30ab-e053-2995a90a7c15	2024-11-13	Warnings	Exact identifier application number: M013
Best Choice Effervescent Antacid Pain Relief	ASPIRIN, CITRIC ACID, SODIUM BICARBONATE	Valu Merchandisers Company	8aab905b-5fe7-dddb-e053-2995a90a6c6f	2024-11-13	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2719840	acetaminophen 675 MG in 15 mL Oral Solution	PSN	5a907289-564c-491b-98d5-d7f43eaaa1b2	4
2719840	acetaminophen 45 MG/ML Oral Solution	SCD	5a907289-564c-491b-98d5-d7f43eaaa1b2	4
2719840	acetaminophen 675 MG per 15 mL Oral Solution	SY	5a907289-564c-491b-98d5-d7f43eaaa1b2	4
2719840	APAP 45 MG/ML Oral Solution	SY	5a907289-564c-491b-98d5-d7f43eaaa1b2	4

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