Indications and uses
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL
- Manufacturer
- A-S Medication Solutions
- Effective date
- 2017-09-07
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 20:24:18
Label at a glance#
ProductNystatin
Active ingredientNYSTATIN
Label structure12 sections
Dosage and administration
INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. CHILDREN AND ADULTS: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). T...
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION
Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula:
Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment.
CLINICAL PHARMACOLOGY
Pharmacokinetics
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur.
Microbiology
Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.
INDICATIONS AND USAGE
Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.
CONTRAINDICATIONS
The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.
PRECAUTIONS
General
This medication is not to be used for the treatment of systemic mycoses.
Discontinue treatment if sensitization or irritation is reported during use.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females.
Pregnancy:
Teratogenic Effects Category C.
Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed.
Nursing Mothers
It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman.
Pediatric Use
ADVERSE REACTIONS
Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General).
Gastrointestinal: Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances.
Dermatologic: Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely.
Other: Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been reported.
OVERDOSAGE
Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects or superinfections (See CLINICAL PHARMACOLOGY: Pharmacokinetics).
DOSAGE AND ADMINISTRATION
INFANTS: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.
CHILDREN AND ADULTS: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.
Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.
HOW SUPPLIED
Product: 50090-0217
NDC: 50090-0217-0 60 mL in a BOTTLE, DROPPER
SPL UNCLASSIFIED SECTION
Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811
8083097
R2/15-R1
Nystatin
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NYSTATIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | Data Matrix | (01)00050090021706(17)991231(10)9987654(21)AA000000 | GTIN-14: 00050090021706 GTIN-12: 050090021706 UPC-A: 050090021706 EAN-13: 0050090021706 GTIN storage (14 digits): 00050090021706 | lbl500900217.jpg |
| Data code | Code 128 | 101800099876541299 | lbl500900217.jpg |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e29fe634-dc25-094c-c77f-5d09c3eceb3e | Product name | 5 | 20260107 |
| e57b6340-9387-3f9a-7307-511c81791375 | Product name | 3 | 20221214 |
| 544f8e8d-6389-eeeb-9586-aa447c08dcc7 | Product name | 5 | 20210614 |
| 1629e00f-54fb-4a43-8306-b58442b23902 | Product name | 9 | 20200430 |
| 854ec07b-1cd7-a5db-235a-7aa24d3cf97a | Product name | 3 | 20180628 |
| 19b9f4c1-15e9-edcc-4c16-f01ecfb5c549 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-0217-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8ce3-f424-e053-dadaa90a57ce | NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-0217-0 | Nystatin | 1 in 1 CARTON | SUSPENSION | 1 | 4 | |
| 50090-0217-0 | Nystatin | 60 mL in 1 BOTTLE, DROPPER | SUSPENSION | 60 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-0217 | NYSTATIN SUSPENSION [A-S MEDICATION SOLUTIONS] | 4 | Legacy NDC, 2 package rows | 20170907_e73b5b84-7af5-4778-bcb3-71e573ce3c50.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-0217-0 | ML - Milliliter | 50090-0217 | d3a8e3e3-99ee-419c-a0c5-8211b27adab7 | 1 | 2019-05-02 |
| 0603-1481-49 | ML - Milliliter | 0603-1481 | 1b0e5187-a61c-49a2-8770-ed137e2f0d73 | 1 | 2012-07-24 |
| 0603-1481-58 | ML - Milliliter | 0603-1481 | c53f8969-0b36-4431-8610-50917d22273a | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Nystatin
- ALCOHOL
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- GLYCERIN
- METHYLPARABEN
- PROPYLPARABEN
- WATER
- SACCHARIN SODIUM
- SODIUM CITRATE, UNSPECIFIED FORM
- SUCROSE
- ANHYDROUS CITRIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50090-0217 | 50090-0217-0 |
| 0603-1481 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| NYSTATIN | BDF1O1C72E | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SUCROSE | C151H8M554 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065148-001 | NYSTATIN | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A065148-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065148-001 | NYSTATIN | 100,000 UNITS/ML | SUSPENSION / ORAL | AA | 2005-06-28 | 3a93d1ddd44b… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A065148-001 | AA | 1 | c2088c7a36db… |
| 2026-09-14 22:38:34 | 2026-08 | A065148-001 | AA | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A065148-001 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A065148-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065148-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A065148-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065148-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065148-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065148-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065148-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065148-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065148-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A065148-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065148-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065148-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065148-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A065148-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065148-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A065148-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A065148-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065148-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065148-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065148-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065148-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065148-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065148-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065148-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065148-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065148-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065148-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A065148-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A065148-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A065148-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A065148-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A065148-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A065148-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A065148-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A065148-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A065148-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A065148-001 | AA | 1 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 670e53be-e033-42f4-952b-5ab47d473815 | e73b5b84-7af5-4778-bcb3-71e573ce3c50 | 2017-09-07 | Adverse reactions | 670e53be-e033-42f4-952b-5ab47d473815 e73b5b84-7af5-4778-bcb3-71e573ce3c50 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.