Indications and uses
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
BromfedDM
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2013-02-05
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:16:26
Label at a glance#
ProductBromfedDM DM
Active ingredientBrompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide
Label structure13 sections
Dosage and administration
Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Rx only
DESCRIPTION
Bromfed® DM Cough Syrup is a clear, light pink syrup with a butterscotch flavor.
Each 5 mL (1 teaspoonful) contains:
Brompheniramine Maleate, USP . . . . . . . . 2 mg
Pseudoephedrine Hydrochloride, USP . . . . . 30 mg
Dextromethorphan Hydrobromide, USP . . . 10 mg
Alcohol 0.95% v/v
In a palatable, aromatic vehicle.
Inactive Ingredients: artificial butterscotch flavor, citric acid anhydrous, dehydrated alcohol, FD&C Red No. 40, glycerin, liquid sugar, methylparaben, propylene glycol, purified water and sodium benzoate. It may contain 10% citric acid solution or 10% sodium citrate solution for pH adjustment. The pH range is between 3.0 and 6.0.
| Brompheniramine Maleate, USP (±)-2- p-Bromo-α-2-(dimethylamino)ethylbenzylpyridine maleate (1:1) |
| Pseudoephedrine Hydrochloride, USP (+)-Pseudoephedrine hydrochloride |
| Dextromethorphan Hydrobromide, USP 3-Methoxy-17-methyl-9α, 13α, 14α -morphinan hydrobromide monohydrate |
Antihistamine/Nasal Decongestant/Antitussive syrup for oral administration.
CLINICAL PHARMACOLOGY
Brompheniramine maleate is a histamine antagonist, specifically an H1-receptor-blocking agent belonging to the alkylamine class of antihistamines. Antihistamines appear to compete with histamine for receptor sites on effector cells. Brompheniramine also has anticholinergic (drying) and sedative effects. Among the antihistaminic effects, it antagonizes the allergic response (vasodilation, increased vascular permeability, increased mucus secretion) of nasal tissue. Brompheniramine is well absorbed from the gastrointestinal tract, with peak plasma concentration after single, oral dose of 4 mg reached in 5 hours; urinary excretion is the major route of elimination, mostly as products of biodegradation; the liver is assumed to be the main site of metabolic transformation.
Pseudoephedrine acts on sympathetic nerve endings and also on smooth muscle, making it useful as a nasal decongestant. The nasal decongestant effect is mediated by the action of pseudoephedrine on α-sympathetic receptors, producing vasoconstriction of the dilated nasal arterioles. Following oral administration, effects are noted within 30 minutes with peak activity occurring at approximately one hour.
Dextromethorphan acts centrally to elevate the threshold for coughing. It has no analgesic or addictive properties. The onset of antitussive action occurs in 15 to 30 minutes after administration and is of long duration.
INDICATIONS AND USAGE
For relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase (MAOI) inhibitors (see Drug Interactions).
Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
WARNINGS
Especially in infants and small children, antihistamines in overdosage may cause hallucinations, convulsions, and death.
Antihistamines may diminish mental alertness. In the young child, they may produce excitation.
PRECAUTIONS
General
Because of its antihistamine component, Bromfed® DM Cough Syrup should be used with caution in patients with a history of bronchial asthma, narrow angle glaucoma, gastrointestinal obstruction, or urinary bladder neck obstruction. Because of its sympathomimetic component, Bromfed® DM Cough Syrup should be used with caution in patients with diabetes, hypertension, heart disease, or thyroid disease.
Information for Patients
Patients should be warned about engaging in activities requiring mental alertness, such as driving a car or operating dangerous machinery.
Drug Interactions
Monoamine oxidase (MAO) inhibitors
Hyperpyrexia, hypotension, and death have been reported coincident with the coadministration of MAO inhibitors and products containing dextromethorphan. In addition, MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines and may enhance the effect of pseudoephedrine. Concomitant administration of Bromfed® DM Cough Syrup and MAO inhibitors should be avoided (see CONTRAINDICATIONS).
Central nervous system (CNS) depressants
Antihistamines have additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, antianxiety agents, etc.).
Antihypertensive drugs
Sympathomimetic may reduce the effects of antihypertensive drugs.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Animal studies of Bromfed® DM Cough Syrup to assess the carcinogenic and mutagenic potential or the effect on fertility have not been performed.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproduction studies have not been conducted with Bromfed® DM Cough Syrup. It is also not known whether Bromfed® DM Cough Syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
Reproduction studies of brompheniramine maleate (a component of Bromfed® DM Cough Syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.
Nursing Mothers
Because of the higher risk of intolerance of antihistamines in small infants generally, and in newborns and prematures in particular, Bromfed® DM Cough Syrup is contraindicated in nursing mothers.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 6 months have not been established (see DOSAGE AND ADMINISTRATION).
ADVERSE REACTIONS
The most frequent adverse reactions to Bromfed® DM Cough Syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include:
Dermatologic: Urticaria, drug rash, photosensitivity, pruritus.
Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation.
CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria.
G.U. System: Urinary frequency, difficult urination.
G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation.
Respiratory System: Tightness of chest and wheezing, shortness of breath.
Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis.
OVERDOSAGE
Signs and Symptoms
Central nervous system effects from overdosage of brompheniramine may vary from depression to stimulation, especially in children. Anticholinergic effects may be noted. Toxic doses of pseudoephedrine may result in CNS stimulation, tachycardia, hypertension, and cardiac arrhythmias; signs of CNS depression may occasionally be seen. Dextromethorphan in toxic doses will cause drowsiness, ataxia, nystagmus, opisthotonos, and convulsive seizures.
Toxic Doses
Data suggest that individuals may respond in an unexpected manner to apparently small amounts of a particular drug. A 2½-year-old child survived the ingestion of 21 mg/kg of dextromethorphan exhibiting only ataxia, drowsiness, and fever, but seizures have been reported in 2 children following the ingestion of 13–17 mg/kg. Another 2½-year-old child survived a dose of 300–900 mg of brompheniramine. The toxic dose of pseudoephedrine should be less than that of ephedrine, which is estimated to be 50 mg/kg.
Treatment
Induce emesis if patient is alert and is seen prior to 6 hours following ingestion. Precautions against aspiration must be taken, especially in infants and small children. Gastric lavage may be carried out, although in some instances tracheostomy may be necessary prior to lavage. Naloxone hydrochloride 0.005 mg/kg intravenously may be of value in reversing the CNS depression that may occur from an overdose of dextromethorphan. CNS stimulants may counter CNS depression. Should CNS hyperactivity or convulsive seizures occur, intravenous short-acting barbiturates may be indicated. Hypertensive responses and/or tachycardia should be treated appropriately. Oxygen, intravenous fluids, and other supportive measures should be employed as indicated.
DOSAGE AND ADMINISTRATION
Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician.
Do not exceed 6 doses during a 24-hour period.
HOW SUPPLIED
Bromfed® DM Cough Syrup is a clear, light pink-colored, butterscotch-flavored syrup containing in each 5 mL (1 teaspoonful) brompheniramine maleate 2 mg, pseudoephedrine hydrochloride 30 mg and dextromethorphan hydrobromide 10 mg, available in the following sizes:
4 fl oz (118 mL) NDC 54868-6377-0
RECOMMENDED STORAGE
Store at 20 ° to 25 °C (68 ° to 77 °F) [See USP Controlled Room Temperature].
KEEP TIGHTLY CLOSED
Dispense in a tight, light-resistant container as defined in the USP.
SPL UNCLASSIFIED SECTION
Rx Only
Product No.: 8837
BROMFED® is a registered trademark of Wockhardt.
Manufactured For:
Wockhardt USA, LLC
Parsippany, NJ 07054
Manufactured By:
Morton Grove Pharmaceuticals, Inc.
Morton Grove, IL 60053
A50-8837-16
REV. 02-10
SPL UNCLASSIFIED SECTION
Distributed by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
BROMFED® DM
COUGH SYRUP
Alcohol 0.95% v/v
DO NOT USE IF INNER FOIL SEAL PRINTED
"SEALED FOR YOUR PROTECTION" IS
BROKEN OR MISSING.
Rx Only
NET: 4 fl oz (118 mL)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1358993 | Bromfed DM 2 MG / 10 MG / 30 MG in 5 mL Oral Solution | PSN | 1 |
| 1357010 | brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG in 5 mL Oral Solution | PSN | 1 |
| 1358993 | brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution [Bromfed DM] | SBD | 1 |
| 1357010 | brompheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Solution | SCD | 1 |
| 1358993 | Bromfed DM (brompheniramine maleate 2 MG / dextromethorphan hydrobromide 10 MG / pseudoephedrine hydrochloride 30 MG) per 5 ML Oral Solution | SY | 1 |
| 1357010 | brompheniramine maleate 2 MG / dextromethorphan HBr 10 MG / pseudoephedrine HCl 30 MG per 5 ML Oral Solution | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| e974e22d-8688-7d92-1e87-40c1079e170c | Product name | 3 | 20151125 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 4f26f669-fc6c-40ef-9e26-1c7b2390ee66 | Product name | 1 | 20140508 |
| 70a83adc-6047-bbea-5a08-dfd304aa47d2 | Product name | 1 | 20140508 |
| 858ce051-9941-aafc-8c7c-44a8e0227463 | Product name | 1 | 20140508 |
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-6377-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-46e8-c013-e053-90daa90a1393 | BROMFED ® DM COUGH SYRUP (Brompheniramine Maleate 2 mg, Pseudoephedrine Hydrochloride 30 mg, and Dextromethorphan Hydrobromide 10 mg) |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-6377-0 | BromfedDM DM | 118 mL in 1 BOTTLE, PLASTIC | SYRUP | 118 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-6377 | BROMFEDDM DM (BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE) SYRUP [PHYSICIANS TOTAL CARE, INC.] | 1 | 1 package rows | 20130206_ccdf22f3-171f-4c19-8273-fefa140d1969.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 60432-837-04 | ML - Milliliter | 60432-837 | dd90841a-bf1d-43d6-a161-ef1dec1be26a | 1 | 2012-07-24 |
| 60432-837-16 | ML - Milliliter | 60432-837 | 98c39b24-f8ba-4a18-b1cd-bafa9d4d020b | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Brompheniramine Maleate | ACTIVE INGREDIENT | IXA7C9ZN03 | 1 | |
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| Pseudoephedrine Hydrochloride | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| Brompheniramine | ACTIVE MOIETY | H57G17P2FN | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| Pseudoephedrine | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| anhydrous citric acid | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| methylparaben | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| raw sugar | INACTIVE INGREDIENT | 8M707QY5GH | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- BromfedDM DM
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
- Brompheniramine Maleate
- Brompheniramine
- Pseudoephedrine Hydrochloride
- Pseudoephedrine
- Dextromethorphan Hydrobromide
- Dextromethorphan
- glycerin
- propylene glycol
- sodium benzoate
- anhydrous citric acid
- alcohol
- methylparaben
- raw sugar
- FD&C Red No. 40
- water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54868-6377 | 54868-6377-0 |
| 60432-837 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Brompheniramine Maleate | IXA7C9ZN03 | ACTIB |
| Pseudoephedrine Hydrochloride | 6V9V2RYJ8N | ACTIB |
| Dextromethorphan Hydrobromide | 9D2RTI9KYH | ACTIB |
| glycerin | PDC6A3C0OX | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| anhydrous citric acid | XF417D3PSL | IACT |
| alcohol | 3K9958V90M | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| raw sugar | 8M707QY5GH | IACT |
| FD&C Red No. 40 | WZB9127XOA | IACT |
| water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SOLUTION / ORAL | 38 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET / ORAL | 30 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION/ DROPS / ORAL | 15 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CLOTH / TOPICAL | 0.05 mg/mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, EXTENDED RELEASE / ORAL | 9 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SHAMPOO / TOPICAL | 0.07 %w/w | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION, CONCENTRATE / INTRAVENOUS | 60 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / ORAL | 26208 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / AURICULAR (OTIC) | 56.55 %w/v | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / SUBCUTANEOUS | 0.16 %w/v | ||
| alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | GUM, CHEWING / BUCCAL | 48 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| FD&C Red No. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET, CHEWABLE / ORAL | 40 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TAMPON / VAGINAL | 62.1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / OPHTHALMIC | 6 %w/v | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION / RESPIRATORY (INHALATION) | 5 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | CAPSULE / ORAL | 8.5 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | FILM, SOLUBLE / BUCCAL | 3 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM / SUBLINGUAL | 11 mg | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | PASTE / DENTAL | 0.08 %w/w | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | ADJ PH | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | POWDER, FOR SOLUTION / ORAL | 126 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | FILM, SOLUBLE / BUCCAL | 2 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION / PERINEURAL | 0.02 %w/v | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GEL / TOPICAL | 3 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| sodium benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | JELLY / TOPICAL | NA | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET, COATED / ORAL | 1 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE, LIQUID FILLED / ORAL | 185 mg | ||
| anhydrous citric acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 414 mg | ||
| propylene glycol | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | SUSPENSION, EXTENDED RELEASE / ORAL | 40 mg | ||
| alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| glycerin | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| glycerin | GLYCERIN | PDC6A3C0OX | SHAMPOO / TOPICAL | 5 %w/w | ||
| methylparaben | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERIDURAL | 1 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 |
|---|---|---|---|---|---|---|---|
| A088811-001 | BROMFED-DM | BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | RLD | 1985-06-07 |
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 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | RLD | 1985-06-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | RLD | 1985-06-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | RLD | 1985-06-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RLD | 1985-06-07 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088811-001 | BROMFED-DM | 2MG/5ML;10MG/5ML;30MG/5ML | SYRUP / ORAL | AA | RS | 1985-06-07 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A088811-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A088811-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A088811-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A088811-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A088811-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A088811-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A088811-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A088811-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A088811-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A088811-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A088811-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A088811-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A088811-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A088811-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A088811-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A088811-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A088811-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A088811-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A088811-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A088811-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A088811-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A088811-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A088811-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A088811-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A088811-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A088811-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A088811-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A088811-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A088811-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A088811-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A088811-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A088811-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A088811-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A088811-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A088811-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A088811-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A088811-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A088811-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A088811-001 | AA | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| 31cfbadd-b2cf-45c1-b28b-266e12c3f8dd | ccdf22f3-171f-4c19-8273-fefa140d1969 | 2013-02-05 | Warnings, Adverse reactions | 31cfbadd-b2cf-45c1-b28b-266e12c3f8dd ccdf22f3-171f-4c19-8273-fefa140d1969 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.