Over-the-counter drug · OTC MONOGRAPH DRUG
Childrens Robitussin Honey Nighttime Cough DM NDC 0031-8762
dextromethorphan hbr, doxylamine succinate · Dextromethorphan hydrobromide 15 mg/10mL; Doxylamine succinate 6.25 mg/10mL · Solution · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0031-8762-12 | 0003187621200031876212 | 1 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLEMarketed from May 27, 2019 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Childrens Robitussin Honey Nighttime Cough DM
- Generic name (nonproprietary)
- dextromethorphan hbr, doxylamine succinate
- Active ingredients
- Dextromethorphan hydrobromide — 15 mg/10mLDoxylamine succinate — 6.25 mg/10mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0031
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0031-8762_350764de-7804-b24e-e063-6394a90ab3c3SPL ID 350764de-7804-b24e-e063-6394a90ab3c3SPL set ID 6afaf85b-bf0c-4c99-acf3-a34f06be20f1RxCUI 1115329UNII 9D2RTI9KYH, V9BI9B5YI2
- Pharmacologic class
- Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N400031876212followed by a unit qualifier and the quantityPackage 00031-8762-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat controls the impulse to cough to help you sleep
Excerpt only. Read the full label for complete information.
About NDC 0031-8762
- What is NDC 0031-8762?
- 0031-8762 is the product NDC for Childrens Robitussin Honey Nighttime Cough DM, Dextromethorphan hydrobromide 15 mg/10mL; Doxylamine succinate 6.25 mg/10mL solution, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Childrens Robitussin Honey Nighttime Cough DM (Dextromethorphan hbr, doxylamine succinate).
- What is the active ingredient?
- Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0031. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Childrens Robitussin Honey Nighttime Cough DM?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| MGC Health Cough Drops Honey Herbmenthol | Menthol 4.8 mg/1 | LozengeOral | Medical Group Care LLC | 83173-133 |
| Multi-Symptom Cold And Flu Relief Nighttimeacetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | RITE AID | 11822-1987 |
| daytime severe cold and fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/15mL + 3 more ingredients | SolutionOral | Kroger Company | 30142-603 |
| TopCare Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | TOPCO ASSOCIATES LLC | 36800-367 |
| Daytime Cold And Fludextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride | Dextromethorphan hydrobromide 10 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Kroger Company | 41226-693 |
| Allergy Reliefdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | FOODHOLD U.S.A., LLC | 41520-290 |
| good sense tussin dmdextromethorphan hydrobromide, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 200 mg/20mL | SolutionOral | A-S Medication Solutions | 50090-7257 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Cough Dropsmenthol | Menthol 7.5 mg/1 | PastilleOral | The Kroger CO | 59450-716 |
| Vicks NyQuil VapoCOOL COLD and FLUacetaminophen, doxylamine succinate, dextromethorphan hydrobromide | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Navajo Manufacturing Company Inc. | 67751-244 |
| Childrens Allergy Relief | Diphenhydramine hydrochloride 12.5 mg/5mL | LiquidOral | Allegiant Health | 69168-471 |
| Severe Cold Plus Flu Daytime Nighttimeacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, and doxylamine succinate | — | Kit | CVS Pharmacy,Inc. | 69842-546 |
| Sinus Pressure and Pain Maximum Strengthacetaminophen, phenylephrine hcl | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | TabletOral | Cardinal Health 110, LLC. DBA Leader | 70000-0161 |
| Mucus Reliefguaifenesin 400 mg | Guaifenesin 400 mg/1 | TabletOral | Pioneer Life Sciences, LLC | 72090-035 |
| Mucinex Childrens Night Time Multi-Symptom Cold and Fluacetaminophen, dextromethorphan hbr, triprolidine hcl | Triprolidine hydrochloride 1.25 mg/10mL + 2 more ingredients | SolutionOral | Reckitt Benckiser LLC | 72854-063 |
| Pharbinex-DMguaifenesin 400mg and dextromethorphan hbr 20mg | Guaifenesin 400 mg/1; Dextromethorphan hydrobromide 20 mg/1 | TabletOral | Ulai Health LLC | 73057-381 |
| MAXIMUM STRENGTH Sinus Relief Day and Night SOFTGELS - 24 ctacetaminophen, dextromethorphan hydrobromide, guaifenesin, doxylamine succinate, phenylephrine hydrochloride | — | Kit | Topco Associates LLC | 76162-679 |
| 24/7 Life Medicated Chest Rubcamphor, eucalyptus oil, menthol ointment | Eucalyptus oil 1.2 g/100g + 2 more ingredients | OintmentTopical | Lil' Drug Store Products, Inc. | 29485-6536 |
| Daytime and Nighttime Cherry Cold and Fludaytime - acetaminophen, dextromethorphan hbr, phenylephrine hcl nighttime - acetaminophen, dextromethorphan hbr, doxylamine succinate | — | KitOral | BETTER LIVING BRANDS, LLC | 21130-967 |
| Daytime Nighttimeacetaminophen, guaifenesin, acetaminophen, dextromethorphan hbr, triprolidine hcl | — | Kit | KROGER COMPANY | 41226-678 |
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