Over-the-counter drug · OTC MONOGRAPH DRUG
Daytime and Nighttime Severe Cold and Flu combo pack NDC 69676-0095
acetaminophen, dextromethorphan hbr, doxylamine succinate · Kit · Oral · Genexa Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69676-0095-3 | 6967600950369676009503 | 2 BOTTLE in 1 KIT (69676-0095-3) / 1 KIT in 1 BOTTLE * 177 mL in 1 BOTTLE (69676-0093-9) * 177 mL in 1 BOTTLE (69676-0094-9)Marketed from Jul 3, 2024 |
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)
- Daytime and Nighttime Severe Cold and Flu combo pack
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hbr, doxylamine succinate
- Dosage form
- Kit
- Route
- Oral
- Labeler
- Genexa Inc.NDC labeler code 69676
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Identifiers
- Product ID 69676-0095_472de7bd-c0e2-bafe-e063-6394a90a5092SPL ID 472de7bd-c0e2-bafe-e063-6394a90a5092SPL set ID 190c7eaf-dcd4-d314-e063-6294a90a6f33RxCUI 2692302, 2693772, 2693777UPC 0850015736643
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
N469676009503followed by a unit qualifier and the quantityPackage 69676-0095-03. 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 reduces fever and relieves these common cold/flu symptoms: minor aches and pains headache sore throat cough due to minor throat and bronchial irritation controls the impulse to cough to help you get to sleep
Excerpt only. Read the full label for complete information.
About NDC 69676-0095
- What is NDC 69676-0095?
- 69676-0095 is the product NDC for Daytime and Nighttime Severe Cold and Flu combo pack kit, listed with the FDA by Genexa Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daytime and Nighttime Severe Cold and Flu combo pack (Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate).
- Who is the labeler?
- Genexa Inc., NDC labeler code 69676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daytime and Nighttime Severe Cold and Flu combo pack?
- 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 013
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 |
|---|---|---|---|---|
| Headache Relief Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | TARGET Corporation | 11673-686 |
| Aspirin Low Dose Chewableaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Better Living Brands, LLC | 21130-397 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Kenvue Brands LLC | 50580-490 |
| Medlineacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Medline Industries, LP | 53329-194 |
| Acetaminophen Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | Aurohealth LLC | 58602-748 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | Marc Glassman, Inc. | 68998-018 |
| Mejoralitoacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | OPMX Chula Vista | 69729-068 |
| Ed Apapacetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | EDWARDS PHARMACEUTICALS, INC. | 0485-0057 |
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Advagen Pharma Limited | 72888-459 |
| pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Kroger Company | 30142-590 |
| equate pain relieveracetaminophen | Acetaminophen 500 mg/1 | TabletOral | Wal-Mart Stores Inc | 49035-308 |
| Tylenol Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-472 |
| Pain Reliefacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | DISCOUNT DRUG MART | 53943-092 |
| aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Publix Super Markets Inc | 56062-274 |
| Acetaminophen Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Aurohealth LLC | 58602-745 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3959 |
| Acetaminophen, Aspirin, Caffeine | Caffeine 65 mg/1 + 2 more ingredients | Tablet, Film coatedOral | CVS Pharmacy, Inc. | 69842-541 |
| Aspirin | Aspirin 325 mg/1 | Tablet, CoatedOral | FSA Store Inc. | 81522-018 |
| Aspirin | Aspirin 325 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-167 |
| Extra Strenght Headache Reliefacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | TabletOral | Lil' Drug Store Products, Inc. | 29485-6538 |
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