Indications and uses
Benzonatate capsules are indicated for the symptomatic relief of cough.
BENZONATATE CAPSULES, USP Rx Only
- Manufacturer
- Proficient Rx LP
- Effective date
- 2019-01-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:32:56
Label at a glance#
ProductBENZONATATE
Active ingredientBENZONATATE
Label structure11 sections
Dosage and administration
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
Label contents#
Full prescribing information#
DESCRIPTION
Benzonatate, a non-narcotic oral antitussive agent, is 2, 5, 8, 11, 14, 17, 20, 23, 26-nonaoxaoctacosan- 28-yl p-(butylamino) benzoate. The molecular formula is C30H53NO11 with a molecular weight of 603.7
Each capsule, for oral administration, contains 100 mg or 200 mg of benzonatate, USP.
Benzonatate Capsules also contain: Alcohol, ammonium hydroxide, D&C Yellow 10, gelatin, glycerin, propylene glycol, purified water, shellac glaze, simethicone and titanium dioxide. In addition, the capsule may contain trace amounts of fractionated coconut oil.
CLINICAL PHARMACOLOGY
Benzonatate acts peripherally by anesthetizing the stretch receptors located in the respiratory passages, lungs, and pleura by dampening their activity and thereby reducing the cough reflex at its source. It begins to act within 15 to 20 minutes and its effect lasts for 3 to 8 hours. Benzonatate capsules have no inhibitory effect on the respiratory center in recommended dosage.
INDICATIONS AND USAGE
Benzonatate capsules are indicated for the symptomatic relief of cough.
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.
WARNINGS
Hypersensitivity
Severe hypersensitivity reactions (including bronchospasm, laryngospasm and cardiovascular collapse) have been reported which are possibly related to local anesthesia from sucking or chewing the capsule instead of swallowing it. Severe reactions have required intervention with vasopressor agents and supportive measures.
Psychiatric Effects
Isolated instances of bizarre behavior, including mental confusion and visual hallucinations, have also been reported in patients taking benzonatate capsules in combination with other prescribed drugs.
Accidental Ingestion and Death in Children
Keep benzonatate capsules out of reach of children. Accidental ingestion of benzonatate capsules resulting in death has been reported in children below age 10. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. If accidental ingestion occurs, seek medical attention immediately (see OVERDOSAGE).
PRECAUTIONS
Benzonatate is chemically related to anesthetic agents of the para-amino-benzoic acid class (e.g. procaine; tetracaine) and has been associated with adverse CNS effects possibly related to a prior sensitivity to related agents or interaction with concomitant medication.
Information for Patients:
Swallow benzonatate capsules whole. Do not break, chew, dissolve, cut or crush benzonatate capsules. Release of benzonatate from the capsule in the mouth can produce a temporary local anesthesia of the oral mucosa and choking could occur. If numbness or tingling of the tongue, mouth, throat, or face occurs, refrain from oral ingestion of food or liquids until the numbness has resolved. If the symptoms worsen or persist, seek medical attention.
Keep benzonatate capsules out of reach of children. Accidental ingestion resulting in death has been reported in children. Signs and symptoms of overdose have been reported within 15-20 minutes and death has been reported within one hour of ingestion. Signs and symptoms may include restlessness, tremors, convulsions, coma and cardiac arrest. If accidental ingestion occurs, seek medical attention immediately.
Overdosage resulting in death may occur in adults.
Do not exceed a single dose of 200 mg and a total daily dosage of 600 mg. If you miss a dose of benzonatate capsules, skip that dose and take the next dose at the next scheduled time. Do not take 2 doses of benzonatate capsules at one time.
Usage in Pregnancy:
Pregnancy Category C. Animal reproduction studies have not been conducted with benzonatate. It is also not known whether benzonatate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Benzonatate capsules should be given to a pregnant woman only if clearly needed.
Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when benzonatate capsules are administered to a nursing woman.
Carcinogenesis, Mutagenesis, Impairment of Fertility:
Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with benzonatate.
Pediatric Use:
Safety and effectiveness in children below the age of 10 have not been established. Accidental ingestion resulting in death has been reported in children below age 10. Keep out of reach of children.
ADVERSE REACTIONS
Potential Adverse Reactions to benzonatate capsules may include:
Hypersensitivity reactions including bronchospasm, laryngospasm, cardiovascular collapse possibly related to local anesthesia from chewing or sucking the capsule.
CNS: sedation; headache; dizziness; mental confusion; visual hallucinations.
GI: constipation; nausea; GI upset.
Dermatologic: pruritus; skin eruptions.
Other: nasal congestion; sensation of burning in the eyes; vague “chilly” sensation; numbness of the chest; hypersensitivity.
Deliberate or accidental overdose has resulted in death, particularly in children.
OVERDOSAGE
Intentional and unintentional overdose may result in death, particularly in children.
The drug is chemically related to tetracaine and other topical anesthetics and shares various aspects of their pharmacology and toxicology. Drugs of this type are generally well absorbed after ingestion.
Signs and Symptoms:
The signs and symptoms of overdose of benzonatate have been reported within 15-20 minutes. If capsules are chewed or dissolved in the mouth, oropharyngeal anesthesia will develop rapidly, which may cause choking and airway compromise.
CNS stimulation may cause restlessness and tremors which may proceed to clonic convulsions followed by profound CNS depression. Convulsions, coma, cerebral edema and cardiac arrest leading to death have been reported within 1 hour of ingestion.
Treatment:
In case of overdose, seek medical attention immediately. Evacuate gastric contents and administer copious amounts of activated charcoal slurry. Even in the conscious patient, cough and gag reflexes may be so depressed as to necessitate special attention to protection against aspiration of gastric contents and orally administered materials. Convulsions should be treated with a short-acting barbiturate given intravenously and carefully titrated for the smallest effective dosage. Intensive support of respiration and cardiovascular-renal function is an essential feature of the treatment of severe intoxication from overdosage.
Do not use CNS stimulants.
DOSAGE AND ADMINISTRATION
Adults and Children over 10 years of age: Usual dose is one 100 mg or 200 mg capsule three times a day as needed for cough. If necessary to control cough, up to 600 mg daily in three divided doses may be given. Benzonatate Capsules should be swallowed whole. Benzonatate Capsules are not to be broken, chewed, dissolved, cut or crushed.
HOW SUPPLIED
Benzonatate capsules, USP 200 mg are clear, yellow liquid filled in oval-shaped softgel capsule, imprinted “134” in white ink. The capsules are available as:
NDC 63187-339-30 Bottles of 30
Store at 20° - 25°C (68° - 77°F). (See USP Controlled Room Temperature).
PROTECT FROM LIGHT.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP TIGHTLY CLOSED.
Distributed by:
Caraco Pharmaceutical Laboratories, Ltd.
Detroit, MI 48202
Repackaged by:
Proficient Rx LP
Thousand Oaks, CA 91320
6351T03
Rev. 04/2014
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL- 200 mg 30 count
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57664-134-88 | EA - Each | 57664-134 | 34d4b01f-5aaa-42a9-8840-198c86492ac5 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| BENZONATATE | ACTIVE INGREDIENT | 5P4DHS6ENR | 1 | |
| BENZONATATE | ACTIVE MOIETY | 5P4DHS6ENR | 1 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| DIMETHICONE | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| GELATIN | INACTIVE INGREDIENT | 2G86QN327L | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MEDIUM-CHAIN TRIGLYCERIDES | INACTIVE INGREDIENT | C9H2L21V7U | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- BENZONATATE
- ALCOHOL
- AMMONIA
- D&C YELLOW NO. 10
- GELATIN, UNSPECIFIED
- GLYCERIN
- PROPYLENE GLYCOL
- WATER
- SHELLAC
- DIMETHICONE
- TITANIUM DIOXIDE
- MEDIUM-CHAIN TRIGLYCERIDES
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63187-339 | 63187-339-30 |
| 57664-134 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZONATATE | 5P4DHS6ENR | ACTIB |
| ALCOHOL | 3K9958V90M | IACT |
| AMMONIA | 5138Q19F1X | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SHELLAC | 46N107B71O | IACT |
| DIMETHICONE | 92RU3N3Y1O | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM, SOLUBLE / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| GELATIN | GELATIN | 2G86QN327L | TABLET, ORALLY DISINTEGRATING / ORAL | 120 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | FILM / BUCCAL | 3 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | ELIXIR / ORAL | 0.3 mg/15ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CONCENTRATE / ORAL | 7000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, COATED / ORAL | 16 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| AMMONIA | AMMONIA SOLUTION | 5138Q19F1X | INJECTION / INTRAVENOUS | 0.22 %w/v | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CAPSULE, LIQUID FILLED / ORAL | 1.51 mg | ||
| SHELLAC | SHELLAC | 46N107B71O | TABLET, SUGAR COATED / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SUSPENSION / ORAL | 76 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAVENOUS | 4000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION / SUBCUTANEOUS | 450 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | GEL / DENTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET / ORAL | 232 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL, METERED / TOPICAL | 1225 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | SOLUTION / ORAL | 8 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUPPOSITORY / VAGINAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO, SUSPENSION / TOPICAL | 2 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MEDIUM-CHAIN TRIGLYCERIDES | MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | GEL / TOPICAL | 12 mg | ||
| GELATIN | GELATIN | 2G86QN327L | CAPSULE, COATED / ORAL | 288 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | CONCENTRATE / ORAL | 0.03 mg/1ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE, DENTIFRICE / DENTAL | 18 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CREAM / TOPICAL | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| AMMONIA | AMMONIA SOLUTION | 5138Q19F1X | CAPSULE / ORAL | 0.01 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | POWDER, FOR SOLUTION / ORAL | NA | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET, CHEWABLE / ORAL | 4 mg | ||
| ALCOHOL | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| GELATIN | GELATIN | 2G86QN327L | POWDER / ORAL | 100 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOAP / TOPICAL | 0.76 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| GELATIN | GELATIN | 2G86QN327L | INJECTION / INTRAVENOUS | 20 mg |
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 |
|---|---|---|---|---|---|---|---|
| A040587-001 | BENZONATATE | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | ||
| A040587-002 | BENZONATATE | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040587-001 | BENZONATATE | 100MG | CAPSULE / ORAL | 2008-03-19 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A040587-002 | BENZONATATE | 200MG | CAPSULE / ORAL | 2008-03-19 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-09-15 20:21 UTC | 2019-09 | A040587-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A040587-002 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A040587-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A040587-002 | AA | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| b8979f4f-e4f3-4f94-a252-23d3e428d669 | 93ab9b1d-7149-4fd9-ab6e-615fad079cd3 | 2021-01-01 | Warnings, Adverse reactions | 93ab9b1d-7149-4fd9-ab6e-615fad079cd3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.