Over-the-counter drug · OTC MONOGRAPH DRUG
Night Time Cold and Flu ReadyInCase NDC 49580-0343
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate · Acetaminophen 650 mg/30mL + 2 more ingredients · Liquid · Oral · P & L Development, LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)49580-0343Labeler and product segments. Claims need a package NDC.
Product NDC at billing width49580-0343Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49580-0343-2 | 4958003430249580034302 | 355 mL in 1 BOTTLE, PLASTIC (49580-0343-2)Marketed from Oct 31, 2014 | |
| 49580-0343-4 | 4958003430449580034304 | 118 mL in 1 BOTTLE, PLASTIC (49580-0343-4)Marketed from Oct 31, 2014 | |
| 49580-0343-6 | 4958003430649580034306 | 177 mL in 1 BOTTLE, PLASTIC (49580-0343-6)Marketed from Oct 31, 2014 | |
| 49580-0343-8 | 4958003430849580034308 | 237 mL in 1 BOTTLE, PLASTIC (49580-0343-8)Marketed from Oct 31, 2014 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Night Time Cold and Flu ReadyInCaseSuffix: ReadyInCase
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate
- Active ingredients
- Acetaminophen — 650 mg/30mLDextromethorphan hydrobromide — 30 mg/30mLDoxylamine succinate — 12.5 mg/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- P & L Development, LLCNDC labeler code 49580
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Marketing end
- Other FDA classes
- Histamine Receptor Antagonists (Mechanism)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 49580-0343_6b8c5604-2fc0-4acb-a71e-0a9ae331fd4eSPL ID 6b8c5604-2fc0-4acb-a71e-0a9ae331fd4eSPL set ID e7dd763b-3005-4723-933b-171eb772afeeRxCUI 1043400UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2UPC 0349580343061
- 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
N449580034302followed by a unit qualifier and the quantityPackage 49580-0343-02. 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 these common cold/flu symptoms: minor aches and pains headache fever sore throat runny nose and sneezing cough due to minor throat and bronchial irritation
Excerpt only. Read the full label for complete information.
About NDC 49580-0343
- What is NDC 49580-0343?
- 49580-0343 is the product NDC for Night Time Cold and Flu ReadyInCase, Acetaminophen 650 mg/30mL + 2 more ingredients liquid, listed with the FDA by P & L Development, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Night Time Cold and Flu ReadyInCase (Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide, Doxylamine succinate.
- Who is the labeler?
- P & L Development, LLC, NDC labeler code 49580. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Night Time Cold and Flu ReadyInCase?
- 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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