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 (Billing 00067-6802-02)
This is a package of THERAFLU Severe Cold Relief Daytime ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl 500 mg/237mL; 20 mg/237mL; 10 mg/237mL Powder, For Solution from Haleon US Holdings LLC, marketed since Jan 2023 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0067-6802-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0067 labeler · 6802 product · 02 package
- Package marketed since
- Jan 20, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0067680202 2
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1189316
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 a powder that you mix with water and take by mouth. It contains acetaminophen, which is typically used to reduce fever and relieve pain, along with dextromethorphan, a cough suppressant. The product also includes phenylephrine, a decongestant commonly used to help relieve nasal congestion. This is an over-the-counter monograph product formulated to address multiple cold symptoms at once.
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 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 mL | 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 |
|---|---|---|---|---|
| 00067-6802-02 You're viewing this Main listing | 6 PACKET in 1 CARTON / 237 mL in 1 PACKET | 2023-01-20 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Theraflu Multi-Symptom Severe Cold 500 mg/237mL; 20 mg/237mL; 10 mg/237mL 00067-6426-06 | Haleon | 6 packets | — | — | FDA listed | — |
| THERAFLU Severe Cold Relief Daytime 500 mg/237mL; 20 mg/237mL; 10 mg/237mLthis 00067-6802-02 | Haleon | 6 packets | — | — | FDA listed | — |
| Multi Symptom Wal Flu Severe Cold 500 mg/1; 20 mg/1; 10 mg 00363-5470-06 | WALGREEN | 6 powders | — | — | FDA listed | — |
| Equate Severe Cold Multi Symptom 500 mg/1; 20 mg/1; 10 mg 49035-0907-91 | Wal-Mart | 6 powders | — | — | FDA listed | — |
| Dg Health Multi Symptom Severe Cold 500 mg/1; 20 mg/1; 10 mg 55910-0509-91 | Dolgencorp, | 6 powders | — | — | FDA listed | — |
| Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM Cold and Flu plus Congestion 500 mg/5g; 10 mg/5g; 20 mg/5g 58933-0550-01 | Procter | 5 g | — | — | FDA listed | — |
| Multi Symptom Severe Cold 500 mg/1; 20 mg/1; 10 mg 68163-0547-06 | RARITAN | 6 powders | — | — | FDA listed | — |
| Basic Care Severe Cold and Flu 500 mg/1; 20 mg/1; 10 mg 72288-0303-91 | Amazon.com | 6 powders | — | — | Discontinued | — |
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 6, 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.
-
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.
-
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.
-
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.
-
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
12 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 6, 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
- 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 Daytime Berry Burst Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride 650 mg; 20 mg; 10 mg Powder NDC 0067-6800-02
- 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 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
- Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, Diphenhydramine HCl Kit NDC 0067-7919-12
- Theraflu Flu Relief Max Strength Daytime Acetaminophen, Dextromethorphan HBr 1000 mg; 30 mg Powder NDC 0067-7921-02
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: minor aches and pains minor sore throat pain headache nasal and sinus congestion 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 6 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 lasts 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 500 mg Dextromethorphan HBr 20 mg Phenylephrine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, flavors, maltodextrin, silicon dioxide, sodium citrate, soy lecithin, sucrose, tribasic calcium phosphate
🎯 Purpose ▾
Purpose s 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 lasts 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.
📄 Questions or Comments ▾
Questions or comments? call 1-855-328-5259
📄 Package Label / Principal Display Panel ▾
Principal Display Panel MULTI-SYMPTOM COLD RELIEF THERAFLU SEVERE COLD RELIEF DAYTIME FORMULA Acetaminophen Pain 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 Honey Lemon Flavor 6 PACKETS 62000000201491 – Front Carton Theraflu Severe Cold Relief Daytime 6 packets
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
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. |