Zodryl DEC 50
- Manufacturer
- CodaDose, Inc. | Gorbec Pharmaceutical Services Inc.
- Effective date
- 2009-08-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:22:34
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT
Codeine phosphate 1 mg/1mL: cough suppressant; Guaifenesin 20 mg/1mL: expectorant; Pseudoephedrine hydrochloride 6 mg/1mL: decongestant
PURPOSE
Temporarily relieves: cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants; the intensity of coughing; the impulse to cough to help you go to sleep; temporarily relieves nasal congestion due to a cold; temporarily restores freer breathing through the nose; helps loosen phlegm (mucus) and thin bronchial passageways of bothersome mucus and makes coughs more productive
Warnings
OTC - DO NOT USE
in children who have chronic pulmonary disease, shortness of breath, or such as occurs with asthma or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor; if taking a monoamine oxidase inhibitor (MAOI)
OTC - ASK DOCTOR
if your child has glaucoma, a breathing problem such as emphysema or chronic bronchitis, heart disease, high blood pressure, thyroid disease, diabetes.
OTC - ASK DOCTOR/PHARMACIST SECTION
if you or your child are taking sedatives or tranquilizers; if you or your child are taking prescription MAOI (certain drugs for depression, psychiatric, or emotional conditions), or for 2 weeks after stopping the MAOI drug.
OTC - WHEN USING THIS PRODUCT
do not exceed recommended dosage; may cause or aggravate constipation; if nervousness, dizziness, or sleepiness occur, discontinue use and consult a doctor
OTC - STOP USE AND ASK A DOCTOR IF
cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persistent headache. These could be signs of a serious condition.
OTC - KEEP THESE AND ALL DRUGS OUT OF REACH OF CHILDREN
In case of overdose, seek professional assistance for contact a Poison Control Center immediately.
Directions:
Take every 4-6 hours
Use only with enclosed calibrated oral dispenser
Do not take more than 4 doses in 24 hours or as directed by a doctor
Children 6 to under 12 years of age: 5mL
Other information store at controlled room temperature 20°-25°C (68°-77°F).
INACTIVE INGREDIENT
Bittermask, citric acid, FD& C blue #1, FD& C red #40, galloquinate, glycerin, grape flavor, magnesium aluminometasilicate, methylparaben, purified water, sodium citrate dihydrate, sucralose, xanthan gum
OTC – QUESTIONS SECTION
Call 1-866-574-8861 24 hours a day, 7 days a week.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1089030 | codeine phosphate 1 MG/ML / guaifenesin 20 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Suspension [Zodryl DEC] | SBD | 1 |
| 1089028 | codeine phosphate 1 MG/ML / guaifenesin 20 MG/ML / pseudoephedrine hydrochloride 6 MG/ML Oral Suspension | SCD | 1 |
| 1089028 | codeine phosphate 1 MG / guaifenesin 20 MG / pseudoephedrine hydrochloride 6 MG per 1 ML Oral Suspension | SY | 1 |
| 1089030 | Zodryl DEC 50 (codeine phosphate 1 MG / guaifenesin 20 MG / pseudoephedrine hydrochloride 6 MG) per 1 ML Oral Suspension | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
| PSEUDOEPHEDRINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43378-124-08 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-c44d-621f-e053-dbdaa90a74ad | ZODRYL DEC 50 - codeine phosphate, guaifenesin and pseudoephedrine hydrochloride suspension |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43378-124-08 | Zodryl DEC 50 | 236 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 236 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43378-124-08 | ML - Milliliter | 43378-124 | 4941c757-0b2a-4da5-8caf-32644371da5c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | 1 | |
| PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 6V9V2RYJ8N | 1 | |
| CODEINE | ACTIVE MOIETY | Q830PW7520 | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | 1 | |
| PSEUDOEPHEDRINE | ACTIVE MOIETY | 7CUC9DDI9F | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | 1 | |
| TANNIC ACID | INACTIVE INGREDIENT | 28F9E0DJY6 | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 1 |
Products#
Every source-derived product name is available through these pages.
- Zodryl DEC 50
- codeine phosphate, guaifenesin and pseudoephedrine hydrochloride
- PSEUDOEPHEDRINE HYDROCHLORIDE
- PSEUDOEPHEDRINE
- CODEINE PHOSPHATE
- CODEINE
- GUAIFENESIN
- ANHYDROUS CITRIC ACID
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- TANNIC ACID
- GLYCERIN
- MAGNESIUM ALUMINUM SILICATE
- METHYLPARABEN
- WATER
- SODIUM CITRATE
- SUCRALOSE
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 43378-124 | 43378-124-08 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PSEUDOEPHEDRINE HYDROCHLORIDE | 6V9V2RYJ8N | ACTIB |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| FD&C BLUE NO. 1 | H3R47K3TBD | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| TANNIC ACID | 28F9E0DJY6 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM CITRATE | 1Q73Q2JULR | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
| XANTHAN GUM | TTV12P4NEE | 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 |
|---|---|---|---|---|---|---|
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | DROPS / ORAL | NA | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | POWDER, FOR SUSPENSION / ORAL | 3 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | POWDER, FOR SOLUTION / ORAL | 414 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SPONGE / TOPICAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / TOPICAL | 216 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | FILM, SOLUBLE / ORAL | 0.04 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRA-ARTICULAR | 0.24 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | DOUCHE / VAGINAL | 1 %w/w | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SOLUTION / ORAL | 10 mg/5ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / ORAL | 32400 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / AURICULAR (OTIC) | 63.64 %w/v | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | CAPSULE, EXTENDED RELEASE / ORAL | 1 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SPRAY / NASAL | 2 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / ORAL | 400 mg | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | TABLET, FILM COATED / ORAL | 0.08 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | TABLET, EXTENDED RELEASE / ORAL | 4 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM, AUGMENTED / TOPICAL | 55 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | ELIXIR / ORAL | NA | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / SUBLINGUAL | ADJ PH | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / ORAL | 46 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / ORAL | 1.13 mg/15ml | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CREAM / VAGINAL | 60 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRAVENOUS | 95 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / ORAL | 1 mg/1ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / ORAL | 388 mg | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | TABLET, CHEWABLE / ORAL | 28 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SUSPENSION/ DROPS / ORAL | 1 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / ORAL | 42 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 3.6 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | POWDER, FOR SUSPENSION / ORAL | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION / TOPICAL | 1971 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | SOLUTION / TOPICAL | 0.01 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | CAPSULE / ORAL | 60 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | TABLET / BUCCAL | 0.01 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / TOPICAL | 0.24 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 0.01 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | CAPSULE / ORAL | 131 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PARENTERAL | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / OPHTHALMIC | 3 mg | ||
| FD&C BLUE NO. 1 | FD&C BLUE NO. 1 | H3R47K3TBD | PASTE, DENTIFRICE / DENTAL | NA | ||
| SUCRALOSE | SUCRALOSE | 96K6UQ3ZD4 | SYRUP / ORAL | 80 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAVENOUS | 772 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| ANHYDROUS CITRIC ACID | ANHYDROUS CITRIC ACID | XF417D3PSL | SOLUTION/ DROPS / AURICULAR (OTIC) | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO, SUSPENSION / TOPICAL | 0.15 %w/w | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SUPPOSITORY / VAGINAL | 227.9 mg | ||
| FD&C RED NO. 40 | FD&C RED NO. 40 | WZB9127XOA | SHAMPOO / TOPICAL | 2 mg |
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 |
|---|---|---|---|---|---|---|
| 5ace705f-df68-4517-b65a-06c468111906 | 2abe5326-bf61-410f-84ea-89a39bd954d0 | 2009-08-24 | 5ace705f-df68-4517-b65a-06c468111906 2abe5326-bf61-410f-84ea-89a39bd954d0 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.


