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 |
|---|---|---|---|---|---|---|
| Equaline Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | United Natural Foods, Inc. dba UNFI | 739237a5-cc62-8ad6-e053-2991aa0a91f8 | 2024-12-17 | Warnings | M013 |
| NOTTS - Muscle Aches and Pain | ACETAMINOPHEN | VIVUNT PHARMA LLC | e6741300-4573-2580-e053-2a95a90a599c | 2024-12-17 | Warnings | M013 |
| Extra Strength Pain Reliever, Caseys 4good | ACETAMINOPHEN 500MG, FILM-COATED CAPLET | Lil' Drug Store Products, Inc. | e5fc5340-c224-e02b-e053-2a95a90a5297 | 2024-12-16 | Warnings | M013 |
| Pain Reliever, Caseys 4good | ACETAMINOPHEN 500 MG, TABLET | Lil' Drug Store Products, Inc. | 039d2cf1-57f6-4d9d-e063-6394a90a5492 | 2024-12-16 | Warnings | M013 |
| Extra Strength Headache, Caseys 4good | ACETAMINOPHEN, ASPIRIN, CAFFEINE TABLET | Lil' Drug Store Products, Inc. | 0425c6a8-a3ea-24ad-e063-6294a90ae15a | 2024-12-16 | Warnings | M013 |
| Lil Drug Store Childrens Pain and Fever | ACETAMINOPHEN | Lil' Drug Store Products, Inc. | 5fcd41ad-449f-4090-be19-eae4171de891 | 2024-12-16 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e75551-1e50-9896-e053-2a95a90aafd4 | 2024-12-14 | Warnings | M013 |
| Acetaminophen 250mg Aspirin 250mg Caffeine 65mg | ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG | CVS Pharmacy | b9e5df0e-06d3-6f72-e053-2995a90a2d07 | 2024-12-14 | Warnings | M013 |
| Alka-Seltzer Heartburn and Pain | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | 2928e140-c868-5bf5-e063-6394a90ab024 | 2024-12-13 | Warnings | M013 |
| foster and thrive pain reliever | ACETAMINOPHEN | Strategic Sourcing Services LLC | b8ee568c-80cf-4e35-865e-35516bdab0fd | 2024-12-13 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | c0de0bd2-4868-46dc-a20f-3ca02caaa26b | 2024-12-11 | Warnings | M013 |
| Rite Aid Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Rite Aid | b4797380-9cef-d640-e053-2a95a90a0665 | 2024-12-11 | Warnings | M013 |
| Top Value Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICAROBONATE | Tower Laboratories Ltd | 44babed8-cf38-1c12-e054-00144ff8d46c | 2024-12-11 | Warnings, Adverse reactions | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | b5e2300a-b77b-53cc-e053-2a95a90a7a6e | 2024-12-11 | Warnings | M013 |
| EXTRA STRENGTH Headache Relief geltabs | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Strive Pharmaceuticals Inc. | b432771a-4f7d-4d39-a038-d1561d8f6708 | 2024-12-11 | Warnings | M013 |
| Pain Relief Childrens | ACETAMINOPHEN | QUALITY CHOICE (Chain Drug Marketing Association) | 223ffb2b-3ee5-4118-955b-bc4fa4e8a2e6 | 2024-12-10 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | UNFI | e689c9e3-dd4d-c646-e053-2a95a90a4b6a | 2024-12-09 | Warnings | M013 |
| DrKids Childrens Pain and Fever | ACETAMINOPHEN 80MG/PIECE | CalmCo LLC | ff4b0528-39a0-80d5-e053-6394a90a8a83 | 2024-12-07 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | DISCOUNT DRUG MART | 972f09a7-2aa1-4b1b-a6dc-2c4578a07803 | 2024-12-05 | Warnings | M013 |
| Pain Relief Extra Strength | ACETAMINOPHEN | DISCOUNT DRUG MART | e6feff0a-3347-194d-e053-2a95a90acd20 | 2024-12-05 | 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 |