Over-the-counter drug · OTC MONOGRAPH DRUG
Theraflu Severe Cold Relief Daytime (Acetaminophen, dextromethorphan hbr) NDC 0067-0100
Acetaminophen 500 mg/1; Dextromethorphan hydrobromide 20 mg/1 · Powder, For solution · Oral · Haleon US Holdings LLC
NDC codes
FDA NDC DirectoryProduct NDC (as listed)0067-0100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00067-0100Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0067-0100-06 | 00067010006 | 6 PACKET in 1 CARTON (0067-0100-06) / 1 POWDER, FOR SOLUTION in 1 PACKETMarketed from Dec 1, 2023 | |
| 0067-0100-99 | 00067010099 | 1000 PACKET in 1 CONTAINER (0067-0100-99) / 1 POWDER, FOR SOLUTION in 1 PACKETMarketed from Jan 1, 2025 |
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)
- Theraflu Severe Cold Relief Daytime
- Generic name (nonproprietary)
- acetaminophen, dextromethorphan hbr
- Active ingredients
- Acetaminophen — 500 mg/1Dextromethorphan hydrobromide — 20 mg/1
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Haleon US Holdings LLCNDC labeler code 0067
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0067-0100_41da2cea-21f3-4162-b20d-ddbc66270b35SPL ID 41da2cea-21f3-4162-b20d-ddbc66270b35SPL set ID 2b962d87-6ff5-4c0f-8504-e5b61c940612RxCUI 2670598UNII 362O9ITL9D, 9D2RTI9KYH
- Pharmacologic class
- 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
N400067010006followed by a unit qualifier and the quantityPackage 00067-0100-06. 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: o minor aches and pains o minor sore throat pain o headache o cough due to minor throat and bronchial irritation • temporarily reduces fever
Excerpt only. Read the full label for complete information.
About NDC 0067-0100
- What is NDC 0067-0100?
- 0067-0100 is the product NDC for Theraflu Severe Cold Relief Daytime, Acetaminophen 500 mg/1; Dextromethorphan hydrobromide 20 mg/1 powder, for solution, listed with the FDA by Haleon US Holdings LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Theraflu Severe Cold Relief Daytime (ACETAMINOPHEN, DEXTROMETHORPHAN HBr).
- What is the active ingredient?
- Acetaminophen, Dextromethorphan hydrobromide.
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0067. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Theraflu Severe Cold Relief Daytime?
- 3 other product NDCs are listed under this name. See all Theraflu Severe Cold Relief Daytime NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Theraflu Severe Cold Relief Daytime products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Theraflu Severe Cold Relief Daytimeacetaminophen, dextromethorphan hbr | Acetaminophen 500 mg/1; Dextromethorphan hydrobromide 20 mg/1 | Powder, For solutionOral | R J General Corporation | 70264-047 | 70264-0047-01 |
| Theraflu Severe Cold Relief Daytimeacetaminophen, dextromethorphan hbr | Acetaminophen 500 mg/1; Dextromethorphan hydrobromide 20 mg/1 | Powder, For solutionOral | Select Consumer Group | 85237-1896 | 85237-1896-0185237-1896-03 |
| THERAFLU Severe Cold Relief Daytimeacetaminophen, dextromethorphan hbr, phenylephrine hcl | Acetaminophen 500 mg/237mL + 2 more ingredients | Powder, For solutionOral | Haleon US Holdings LLC | 0067-6802 | 00067-6802-02 |
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 |
|---|---|---|---|---|
| Cold and Flu HBPacetaminophen, chlorpheniramine maleate | Acetaminophen 325 mg/1; Chlorpheniramine maleate 2 mg/1 | Tablet, Film coatedOral | WALMART INC. | 79903-120 |
| Equate Daytime Nighttime Vapor Ice Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | — | Kit | WALMART INC. | 79903-417 |
| Night Time Cold and Flu ReadyInCaseacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | P & L Development, LLC | 49580-0343 |
| Sinus Severeacetaminophen, guaifenesin, phenylephrine hcl | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, Film coatedOral | L.N.K. International, Inc. | 50844-572 |
| SUDAFED PE Head Congestion Plus Flu Severeacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, Film coatedOral | Kenvue Brands LLC | 50580-450 |
| Nighttime severe cold and fluacetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/30mL + 3 more ingredients | LiquidOral | TARGET CORPORATION | 11673-828 |
| Freegells Cough Drops Menthol Cherry 30ctmenthol | Levomenthol 5.8 mg/1 | LozengeOral | RL Albert & Son Inc. | 83002-040 |
| Sanatosmenthol | Menthol 5.4 mg/1 | LozengeOral | Pharmadel LLC | 55758-518 |
| Pressure and Pain Plus Mucus PEacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | VALU MERCHANDISERS COMPANY | 63941-173 |
| Supress Adexbromopheniramine maleate, dextromethorphan hbr, phenylephrine hcl | Dexbrompheniramine maleate 1 mg/mL + 2 more ingredients | SyrupOral | Dextrum Laboratories, Inc | 65852-020 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hbr and doxylamine succinate | Acetaminophen 325 mg/1 + 2 more ingredients | CapsuleOral | Chain Drug Consortium, LLC | 68016-878 |
| Head Congestion plus Flu Severe PEacetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 3 more ingredients | Tablet, CoatedOral | HARRIS TEETER | 72036-274 |
| Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttimeacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl | Acetaminophen 1000 mg/30mL + 3 more ingredients | SyrupOral | Haleon US Holdings LLC | 0067-0114 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Nightdextromethorphan hbr, doxylamine succinate, guaifenesin | — | Kit | WALMART INC. | 79903-414 |
| Meijer Adult MS Severe Multi-Symptom Cough Cold Fluaacetaminophen, dextromethorphan hbr and guaifenesi | Acetaminophen 650 mg/20mL + 2 more ingredients | LiquidOral | MEIJER DISTRIBUTION INC | 79481-6308 |
| Menthol Cough Dropsmenthol | Menthol 5.8 mg/1 | PastilleOral | Target Corporation Inc. | 82442-001 |
| adult dm max cough and chest congestiondextromethorphan hbr, guaifenesin | Dextromethorphan hydrobromide 20 mg/20mL; Guaifenesin 400 mg/20mL | SolutionOral | Meijer Distribution Inc | 41250-261 |
| Bio-Rytusschlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride | Chlorpheniramine maleate 2 mg/5mL + 2 more ingredients | LiquidOral | Advanced Generic Corporation | 45737-250 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 50 mg/1 | TabletOral | AMERISOURCE BERGEN | 46122-829 |
| Cold Relief Multi-Symptomacetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl | — | Kit | L.N.K. International, Inc. | 50844-529 |
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