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.
| 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 |
|---|---|
| ACETAMINOPHEN | 675 mg/15mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2719840 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 5a907289-564c-491b-98d5-d7f43eaaa1b2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
FDA-Initiated Inactive NDC Indexing#
| 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 | 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#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | P & L Development, LLC | 55e996cd-ef22-4e09-a05c-8aa994e4540b | 2026-06-12 | Warnings | M013 |
| CHILDRENS TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | 3162733b-9382-39f1-e063-6294a90ac420 | 2026-06-12 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | Dr. Reddy's Laboratories Inc. | 9769e0c0-2f4c-3b7a-1a65-c98fbce11681 | 2026-06-12 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | NuCare Pharmaceuticals, Inc. | 54010ddf-25d1-2016-e063-6294a90a877d | 2026-06-11 | Warnings | M013 |
| ACETAMINOPHEN | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | 983debdf-4a61-4dde-ba34-567fdd17720e | 2026-06-11 | Warnings | M013 |
| Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl Liquid | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | WALGREENS | 40b4fe91-b1dd-147c-e063-6294a90a807d | 2026-06-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PUBLIX SUPERMARKETS, INC | 3f17fa06-4932-b8ec-e063-6294a90a0381 | 2026-06-09 | Warnings | M013 |
| Sleep Aid Plus Pain Relief | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | e3929179-dad2-4f7e-a971-dbf80f2b5e1b | 2026-06-08 | Warnings | M013 |
| LOW DOSE ASPIRIN | ASPIRIN | Pinnacle RX LLC | 53c11fb4-ba31-b5e5-e063-6394a90a9c1a | 2026-06-08 | Warnings | M013 |
| Pain Reliever PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Walgreen Company | 9655c38a-126b-459e-b31d-0aa33d9eb522 | 2026-06-08 | Warnings | M013 |
| Acetaminophen Regular Strength | ACETAMINOPHEN | Aurohealth LLC | dce938f5-eeba-4a76-9261-2b1324c39a31 | 2026-06-08 | Warnings | M013 |
| Childrens Mapap | ACETAMINOPHEN | Bryant Ranch Prepack | 69c90cc8-846a-42cf-933a-108671689e8f | 2026-06-05 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Rugby Laboratories | 63fcd93a-b1db-44ba-8f2b-055a7deb205d | 2026-06-04 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | ASCLEMED USA INC. | 707a9ea7-8f4e-4274-97bd-b8071a0ee06b | 2026-06-04 | Warnings | M013 |
| Aspirin Adult low dose | ACETYLSALICYCLIC ACID | Medline Industries, LP | 6dd6501f-841c-4994-e053-2a91aa0ae231 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5e6f2a-e813-0666-e053-6394a90a66a7 | 2026-06-04 | Warnings | M013 |
| Medline | ACETAMINOPHEN | Medline Industries, LP | fc5d92c2-4bbe-8ad1-e053-6294a90a65b6 | 2026-06-04 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Unit Dose Solutions, Inc. | 537219ac-552a-a30e-e063-6394a90aa9d1 | 2026-06-04 | Warnings | M013 |
| Pain Relief childrens | ACETAMINOPHEN | CVS PHARMACY | ff878f56-125a-4de7-b063-029f7030733d | 2026-06-04 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | CVS Pharmacy | 749e2be2-594a-4052-8fa5-45c9ade2d23c | 2026-06-03 | Warnings | M013 |
DailyMed RxNorm Mappings#
| 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 | 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 |