Theraflu Severe Cold Relief Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride 650 mg; 20 mg; 10 mg Powder, 6-count — NDC 0067-6800-02 (Billing 00067-6800-02)
This is a package of 6 powders of Theraflu Severe Cold Relief Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride 650 mg; 20 mg; 10 mg Powder from Haleon US Holdings LLC, marketed since Jan 2022 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0067-6800-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0067 labeler · 6800 product · 02 package
- Package marketed since
- Jan 20, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Billing quantity
- 6 EA per package
- Barcode (UPC-A, from the NDC)
- 3 0067680002 8
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 064452
- GCN: 14355
- HICL (First Databank): 008885
- AHFS class code: 12:12.04.00
- RxCUI (RxNorm): 1659967
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Anilides class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Read the full MedlinePlus article ↗Theraflu Severe Cold Relief Daytime is an over-the-counter oral powder containing acetaminophen, dextromethorphan, and phenylephrine. Acetaminophen is typically used to reduce fever and relieve pain, while dextromethorphan is commonly used to suppress coughs. Phenylephrine functions as a nasal decongestant to help relieve congestion. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for cold and flu symptom relief products.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00067-6800-02 You're viewing this Main listing | 6 POWDER in 1 CARTON | 2022-01-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Theraflu PowerPods Daytime Severe Cold 650 mg/1; 20 mg/1; 10 mg 00067-6094-01 | Haleon | 8 pouches | — | — | FDA listed | — |
| Theraflu Severe Cold Relief Daytime Berry Burst 650 mg/1; 20 mg/1; 10 mgthis 00067-6800-02 | Haleon | 6 powders | — | — | FDA listed | — |
| Theraflu Daytime Severe Cold and Cough 650 mg/1; 20 mg/1; 10 mg 00067-7917-06 | Haleon | 6 packets | — | — | FDA listed | — |
| Theraflu Severe Cold Relief Daytime with Honey Ginger Flavor 650 mg/1; 20 mg/1; 10 mg 00067-8211-01 | Haleon | 6 packets | — | — | FDA listed | — |
| SanaTos Severe Cold and Cough Daytime 650 mg/1; 20 mg/1; 10 mg 55758-0384-06 | Pharmadel | 6 granules | — | — | FDA listed | — |
| Severe Cold and Cough Daytime 650 mg/1; 20 mg/1; 10 mg 67091-0322-06 | WinCo | 6 packets | — | — | FDA listed | — |
| severe cold and cough daytime 650 mg/1; 20 mg/1; 10 mg 68163-0540-06 | RARITAN | 6 powders | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 8, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 23OV73Q5G9
Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
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UNII XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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UNII Z0H242BBR1
Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
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UNII 7CVR7L4A2D
A starch-derived carbohydrate produced by breaking down corn, potato, or tapioca starch. It functions as a filler and binder to give the medicine bulk and texture, and sometimes as a mild sweetener or texture enhancer in powders and tablets.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 91D9GV0Z28
A mineral salt made from calcium and phosphate. It acts as a filler to add bulk to the tablet or capsule, and helps bind ingredients together so the medicine holds its shape.
11 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 8, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Haleon US Holdings LLC labeler code 00067
- Theraflu PowerPods Daytime Severe Cold ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE 650 mg; 20 mg; 10 mg Powder, For Solution NDC 0067-6094-01
- Theraflu Powerpods Nighttime Severe Cold Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl 650 mg; 25 mg; 10 mg Powder, For Solution NDC 0067-6095-01
- Gas-X Ultra Strength AntiGas Softgels Simethicone 180 mg Capsule, Liquid Filled NDC 0067-6274-18
- Gas-X Extra Strength Softgels Simethicone 125 mg Capsule, Liquid Filled NDC 0067-6275-01
- Gas-X Maximum Strength Softgels Simethicone 250 mg Capsule, Liquid Filled NDC 0067-6283-01
- THERAFLU MULTI-SYMPTOM SEVERE COLD ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 500 mg/237mL; 20 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6426-06
- Theraflu Severe Cold relief Nighttime Acetaminophen, Diphenhydramine Hydrochloride, Phenylephrine Hydrochloride 500 mg; 25 mg; 10 mg Powder NDC 0067-6801-02
- THERAFLU Severe Cold Relief Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 500 mg/237mL; 20 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6802-02
- Theraflu Severe Cold Relief Nighttime ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl 650 mg/237mL; 25 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-6803-02
- Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl Kit NDC 0067-6804-02
- Theraflu Daytime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE 650 mg; 20 mg; 10 mg Powder, For Solution NDC 0067-7917-06
- THERAFLU NIGHTTIME SEVERE COLD AND COUGH ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL 650 mg/237mL; 25 mg/237mL; 10 mg/237mL Powder, For Solution NDC 0067-7918-06
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 Indications and Usage ▾
Uses • temporarily relieves these symptoms due to a cold: o minor aches and pains o minor sore throat pain o headache o nasal and sinus congestion o cough due to minor throat and bronchial irritation • temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions • do not use more than directed • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor. Age Dose adults and children 12 years of age and over one packet children under 12 years of age do not use • dissolve contents of one packet into 8 oz. hot water; sip while hot.
Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water; stir briskly before and after heating. Do not overheat.
⚠️ Warnings ▾
Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting consult a doctor promptly. Do Not Use • in a child under 12 years of age • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.
If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin When using this product • do not exceed recommended dosage Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion gets worse or last more than 7 days • cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
🧪 Active Ingredient ▾
Active ingredients (in each packet) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
🎯 Purpose ▾
Purposes Pain reliever/Fever reducer Cough suppressant Nasal decongestant
📄 Do Not Use ▾
Do Not Use • in a child under 12 years of age • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
📄 Ask a Doctor Before Use If ▾
Ask a doctor before use if you have • liver disease • heart disease • high blood pressure • thyroid disease • diabetes • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are • taking the blood thinning drug warfarin
📄 When Using This Product ▾
When using this product • do not exceed recommended dosage
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if • nervousness, dizziness, or sleeplessness occurs • fever gets worse or lasts more than 3 days • redness or swelling is present • new symptoms occur • pain, cough or nasal congestion gets worse or last more than 7 days • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
📄 Other Information ▾
Other information • each packet contains : potassium 10 mg, sodium 20 mg • phenylketonurics : contains phenylalanine 14 mg per packet • store at controlled room temperature 20 - 25°C (68 - 77°F). Protect product from heat and moisture.
📄 Questions or Comments ▾
Questions or Comments? call 1-855-328-5259
📄 Package Label / Principal Display Panel ▾
Principal Display Panel HALEON NDC 0067-6800-02 MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF DAYTIME FORMULA ACETAMINOPHEN Paint Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant PHENYLEPHRINE HCl Nasal Decongestant Hot liquid therapy that relieves: / Nasal and sinus congestion / Cough / Sore throat pain / Headache / Fever Berry Burst Flavor 6 PACKETS Y:\HAL-CH Drug Listing\CH WORKING\Theraflu Berry Burst 0067-6800\Theraflu Severe Cold Relief Berry Burst 6 Packets.JPG
About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |