Over-the-counter drug · OTC MONOGRAPH DRUG
Nighttime Severe Cold and Cough NDC 41226-541
acetaminophen, diphenhydramine, phenylephrine · Acetaminophen 650 mg/1 + 2 more ingredients · Powder, For solution · Oral · KROGER COMPANY
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 41226-541-06 | 4122605410641226054106 | 6 POWDER, FOR SOLUTION in 1 CARTON (41226-541-06)Marketed from Jan 15, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Nighttime Severe Cold and Cough
- Generic name (nonproprietary)
- acetaminophen, diphenhydramine, phenylephrine
- Active ingredients
- Acetaminophen — 650 mg/1Diphenhydramine hydrochloride — 25 mg/1Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- KROGER COMPANYNDC labeler code 41226
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 010
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 41226-541_6274b9f7-e082-4696-9877-e1ba783d98c0SPL ID 6274b9f7-e082-4696-9877-e1ba783d98c0SPL set ID 7def6781-0881-46bf-ad7a-7a3f23a8d9f7RxCUI 1659960UNII 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ
- Pharmacologic class
- Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
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
N441226054106followed by a unit qualifier and the quantityPackage 41226-0541-06. 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 symptoms due to a cold: ▪ minor aches and pains ▪ minor sore throat pain ▪ headache ▪ nasal and sinus congestion ▪ runny nose ▪ sneezing ▪ itchy nose or throat ▪ itchy, watery eyes due to hay fever ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 41226-541
- What is NDC 41226-541?
- 41226-541 is the product NDC for Nighttime Severe Cold and Cough, Acetaminophen 650 mg/1 + 2 more ingredients powder, for solution, listed with the FDA by KROGER COMPANY. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nighttime Severe Cold and Cough (Acetaminophen, Diphenhydramine, Phenylephrine).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride, Phenylephrine hydrochloride.
- Who is the labeler?
- KROGER COMPANY, NDC labeler code 41226. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nighttime Severe Cold and Cough?
- 2 other product NDCs are listed under this name. See all Nighttime Severe Cold and Cough NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nighttime Severe Cold and Cough products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nighttime Severe Cold and Coughacetaminophen, diphenhydramine hcl, phenylephrine hcl | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0502 | 49580-0502-08 |
| Nighttime Severe Cold and Coughacetaminophen, diphenhydramine, phenylephrine | Acetaminophen 650 mg/1 + 2 more ingredients | Powder, For solutionOral | RARITAN PHARMACEUTICALS INC | 68163-541 | 68163-0541-06 |
Other NDCs under M 010
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 |
|---|---|---|---|---|
| Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen | Diphenhydramine hydrochloride 50 mg/30mL; Acetaminophen 1000 mg/30mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-985 |
| Nighttime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BJWC (Berkley & Jensen / BJ's) | 68391-793 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 49035-736 |
| Diphenhydramine HCl 25mgsleep aid | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | Allegiant Health | 69168-002 |
| berkley and jensen sleep aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/30mL | SolutionOral | BJWC | 68391-186 |
| AXIV - VroZzzdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Vivunt Pharma LLC | 82706-014 |
| Revasol Sleep Aiddiphenhydramine hcl | Diphenhydramine HCl 50 mg/30mL | LiquidOral | Rnv LLC | 84379-284 |
| Vicks ZzzQuil Night Paindiphenhydramine hydrochloride and acetaminophen | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | Tablet, CoatedOral | The Procter & Gamble Manufacturing Company | 37000-974 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-860 |
| Sleep Tabsdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Major Pharmaceuticals | 0904-4274 |
| Nightime Sleep Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/30mL | LiquidOral | BETTER LIVING BRANDS LLC. | 21130-711 |
| Diphenhydramine HCl | Diphenhydramine HCl 50 mg/30mL | LiquidOral | BI-MART | 37835-519 |
| Sleep Aid NightTimediphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Wal-Mart Stores Inc | 49035-672 |
| Nighttime sleep aid Maximum Strengthdiphenhydramine hydrochloride | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Best Choice (Valu Merchandisers Company) | 63941-916 |
| Nighttime Sleep-Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | BIONPHARMA INC. | 69452-427 |
| Diphenhydramine Hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | AAA Pharmaceutical, Inc. | 57344-091 |
| Sleep Aid | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Better Living Brands LLC | 21130-052 |
| Sleep Aiddiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | CapsuleOral | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 55910-894 |
| Quality Choice Nighttime Sleep-Aiddiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | Capsule, Liquid filledOral | Chain Drug Marketing Association, Inc. | 63868-970 |
| Nighttime Sleep Aiddiphenhydramine hcl 50mg | Diphenhydramine hydrochloride 50 mg/1 | Capsule, Liquid filledOral | Grocery Outlet | 85828-410 |
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