Theraflu Severe Cold Relief Soft Chews Acetaminophen, Dextromethorphan HBr 325 mg; 10 mg Tablet, Chewable, 10-count — NDC 0067-0111-02 (Billing 00067-0111-02)
This is a package of 10 tablets of Theraflu Severe Cold Relief Soft Chews Acetaminophen, Dextromethorphan HBr 325 mg; 10 mg Tablet, Chewable from Haleon US Holdings LLC, marketed since Jun 2024 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 0067-0111-02 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 0067 labeler · 0111 product · 02 package
- Package marketed since
- Jun 19, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 0067011102 1
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 2685209
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 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
Theraflu Severe Cold Relief Soft Chews is a chewable tablet taken by mouth that combines two over-the-counter active ingredients. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Dextromethorphan hydrobromide is commonly used to suppress cough. This product is marketed as an OTC monograph drug, meaning it follows FDA's established safety and effectiveness guidelines for over-the-counter cold and cough preparations.
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 3, 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 each | 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 4, 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 |
|---|---|---|---|---|
| 00067-0111-01 0067-0111-01 Main listing | 20 TABLET, CHEWABLE in 1 BOTTLE | 2024-06-19 | — | Active |
| 00067-0111-02 You're viewing this | 10 TABLET, CHEWABLE in 1 BOTTLE | 2024-06-19 | — | Active |
You're viewing the smallest of 2 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 00067-0111-01?
What NDC number is used to bill for this package of Theraflu Severe Cold Relief Soft Chews Acetaminophen, Dextromethorphan HBr 325 mg; 10 mg Tablet, Chewable?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Theraflu Severe Cold Relief Soft Chews 325 mg/1; 10 mgthis 00067-0111-02 | Haleon | 10 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 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 3, 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 LMI26O6933
Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
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UNII CZN0MI5R31
A calcium salt derived from gluconic acid, used as a mineral supplement and buffering agent. It helps maintain pH balance and provides calcium fortification in formulations.
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UNII UTY7PDF93L
A plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII R12CBM0EIZ
A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
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UNII 9G5L16BK6N
A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
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UNII 917J3173FT
Cow milk is a natural liquid from dairy cattle containing proteins, fats, and lactose. It's used in medicines as a source of lactose (a filler and sweetener) and milk proteins that can help bind ingredients together in tablets and capsules.
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UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
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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 H77VEI93A8
A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII R6Q3791S76
Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 8KW3E207O2
A liquid sweetener made from sorbitol, a sugar alcohol derived from glucose. It sweetens the medicine and also acts as a humectant to help retain moisture and improve texture in liquid formulations.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
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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.
17 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 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 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 Severe Cold Relief Chest Congestion Daytime Acetaminophen, Dextromethorphan HBr, Guaifenesin 650 mg/30mL; 20 mg/30mL; 400 mg/30mL Syrup NDC 0067-0104-08
- Theraflu Severe Cold Relief Nighttime Acetaminophen, Diphenhydramine HCl 650 mg/30mL; 25 mg/30mL Syrup NDC 0067-0105-08
- Theraflu Severe Cold Relief Daytime Berry Burst ACETAMINOPHEN, DEXTROMETHORPHAN HBr 650 mg; 20 mg Powder, For Solution NDC 0067-0106-06
- Theraflu Severe Cold Relief Acetaminophen, Dextromethorphan HBr, Diphenphydramine HCl, Guaifenesin Kit NDC 0067-0107-01
- Theraflu Severe Congestion Relief Cooling Nasal Mist Oxymetazoline HCl .5 mg/mL Spray NDC 0067-0109-01
- Theraflu Severe Congestion Relief Nasal Mist Oxymetazoline HCl .5 mg/mL Spray NDC 0067-0110-01
- Theraflu Severe Cold Relief Nighttime Soft Chews Acetaminophen, Diphenhydramine HCl 325 mg; 12.5 mg Tablet, Chewable NDC 0067-0112-01
- Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Nighttime Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Pseudoephedrine HCl 1000 mg/30mL; 4 mg/30mL; 30 mg/30mL; 60 mg/30mL Syrup NDC 0067-0114-01
- Theraflu-D Flu Relief Max Strength plus Nasal Decongestant Acetaminophen, Dextromethorphan HBr, Pseudoephedrine HCl 1000 mg/30mL; 30 mg/30mL; 60 mg/30mL Syrup NDC 0067-0115-01
- Gas-X Extra Strength Simethicone 125 mg Tablet, Chewable NDC 0067-0117-01
- Gas-X Total Relief Maximum Strength Calcium carbonate, Simethicone 750 mg; 250 mg Tablet, Chewable NDC 0067-0118-01
- Gas-X Total Relief Maximum Strength Calcium carbonate, Simethicone 750 mg; 250 mg Tablet, Chewable NDC 0067-0119-01
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 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 ▪ sore throat pain ▪ headache ▪ cough due to minor throat and bronchial irritation ▪ temporarily reduces fever
⏱️ Dosage and Administration ▾
Directions ▪ do not use more than directed ▪ do not take more than 10 chewable tablets in 24 hours unless directed by a doctor. Take every 4 hours, while symptoms persist. Age Dose adults and children 12 years of age and over take 2 chewable tablets every 4 hours children under 12 years of age do not use
⚠️ 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 ▪ 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 Stop use and ask a doctor if ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain or cough 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 chewable tablet) Acetaminophen 325 mg Dextromethorphan equivalent to 10 mg Dextromethorphan HBr
🧪 Inactive Ingredients ▾
Inactive ingredients calcium gluconate monohydrate, carboxymethylcellulose calcium, carnauba wax, corn syrup solids, crospovidone, FD&C red no. 40 aluminum lake, FD&C yellow no. 6 aluminum lake, glycerin, mannitol, natural and artificial flavors, pregelatinized starch, simethicone, sodium gluconate, sorbitol, sorbitol solution, sucralose, sucrose, whole dry milk
🎯 Purpose ▾
Purposes Pain reliever/Fever reducer Cough suppressant
📄 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 ▪ 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
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if ▪ fever gets worse or lasts more than 3 days ▪ redness or swelling is present ▪ new symptoms occur ▪ pain or cough 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 1-855-328-5359
📄 Package Label / Principal Display Panel ▾
Package/Label Principal Display Panel NEW THERAFLU SEVERE COLD RELIEF SOFT CHEWS Acetaminophen Pain Reliever/Fever Reducer Dextromethorphan HBr Cough Suppressant FAST relief ANYWHERE cough / sore throat / headache / body aches / fever 20 CHEWABLE TABLETS Chew tablets completely before swallowing Apple Cinnamon Flavor Theraflu SCR Soft Chews Daytime 20ct
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. |