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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	H E B	c713556c-cb9e-4ed2-bc2f-49b3d6256c0f	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Exact identifier application number: M013
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Exact identifier application number: M013
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Hi-Tech Nutraceuticals, LLC	b119ba37-0ee3-851a-e053-2995a90a85b1	2026-03-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	ad01aea6-4af3-469b-b99d-e1e66aa40e8d	2026-03-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	804d4b63-1bbe-47c0-ad49-39ddbeade6a3	2026-03-25	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	HyVee Inc	9d9c2bf6-8660-4987-8794-936d3102da8d	2026-03-24	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	BJWC (Berkley & Jensen / BJ's)	851228ea-eaf3-452b-a9ce-8cd244a0eaf3	2026-03-24	Warnings	Exact identifier application number: M013
FirstCare Childrens Pain Fever Acetaminophen	ACETAMINOPHEN 80 MG	USpharma Ltd	9fc05ba6-5667-457e-82c1-a8b4e16cadda	2026-03-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Exact identifier application number: M013
Chewable Aspirin Low Dose	CHEWABLE ASPIRIN	Grocery Outlet	609c0389-8bed-4483-84fa-73ee73fdb4e4	2026-03-20	Warnings	Exact identifier application number: M013
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Exact identifier application number: M013
Rapidol	ACETAMINOPHEN	Pharmadel LLC	3a210860-1fc1-e496-e063-6394a90a8705	2026-03-20	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