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 |
|---|---|---|---|---|
| Acetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | COSTCO WHOLESALE CORPORATION | 63981-019 |
| Extra Strength Pain Releifacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Strategic Sourcing Services, LLC | 70677-1242 |
| Aspirin 81 mgaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | H E B | 37808-600 |
| TYLENOL Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1001 |
| Extra Strength Pain Relieveracetaminophen tablets 500 mg | Acetaminophen 500 mg/1 | TabletOral | WALGREENS | 0363-0669 |
| Pain Relieveracetaminophen capsules 500mg (minis-red opaque) | Acetaminophen 500 mg/1 | Capsule, Liquid filledOral | Walgreens | 0363-6684 |
| Mommys Bliss Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-793 |
| Childrens Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | CVS Pharmacy | 59779-126 |
| Good Neighbor Pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-211 |
| Acetaminophen | Acetaminophen 160 mg/5mL | LiquidOral | A-S Medication Solutions | 50090-6059 |
| Members Mark Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sam's West Inc | 68196-606 |
| Mommys Bliss Infants Pain and Feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Mom Enterprises, LLC. | 71444-893 |
| Thompson Extra Strength Non-Aspirinacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Thompson | 73408-174 |
| Aspirin 81 mg Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-089 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-222 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | P & L Development, LLC | 49580-0282 |
| Dye Free Pain and Fever Childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreens | 0363-0285 |
| Pain Reliever Extra Strengthacetaminophen | Acetaminophen 500 mg/1 | Tablet, CoatedOral | Walgreen Company | 0363-0519 |
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