Theraflu Severe Cold Relief Daytime Berry Burst
- Product NDC
- 0067-6800
- 11-digit product format
- 000676800
- Labeler code
- 0067
- Product ID
- 0067-6800_77b6db34-5ac4-46a5-9d6d-1c4cc83a9ba9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Phenylephrine Hydrochloride
- Dosage form
- POWDER
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-01-20
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theraflu Severe Cold Relief Daytime Berry Burst
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1659967 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ebbb2f4b-ba84-40ad-96f6-60225119a33b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-6800-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-377c-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6800-02 | Theraflu Severe Cold Relief Daytime Berry Burst | 6 in 1 CARTON | POWDER | 6 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-6800-02 | EA - Each | 0067-6800 | a77a4080-ed09-43f5-ab5c-0dd6b78f56c1 | 1 | 2024-03-12 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-6800 | THERAFLU SEVERE COLD RELIEF DAYTIME BERRY BURST (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HYDROCHLORIDE) POWDER [HALEON US HOLDINGS LLC] | 3 | Current NDC, 1 package rows | 20240229_ebbb2f4b-ba84-40ad-96f6-60225119a33b.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Sinus PE Head Congestion and Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Better Living Brands, LLC | 28a4ec37-11dd-4134-81aa-851f081bf088 | 2026-08-17 | Warnings | M012 |
| CVS Health No Drip | NASAL MIST | CVS PHARMACY,INC. | 60ee7bd2-0d7c-4228-a559-0d5dbd3d44fa | 2026-08-17 | Warnings | M012 |
| Daytime Cold and Cough and NightTime Cold and Congestion Childrens | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Walgreens | 2bdc62b6-f3e1-4a79-9b29-00cc1d4280b3 | 2026-08-17 | Warnings | M012 |
| CVS Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | CVS HEALTH | f01ab8ef-d29a-4e33-8a14-4c57ccdcc0d6 | 2026-08-17 | Warnings | M012 |
| Daytime Nighttime | ACETAMINOPHEN, GUAIFENESIN, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | KROGER COMPANY | 30d50bbe-0a14-c985-e063-6294a90a47b3 | 2026-08-16 | Warnings | M012 |
| Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | ARMY AND AIR FORCE EXCHANGE SERVICE | 77f87e19-a9d5-479d-9434-bbde13210bfb | 2026-08-15 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Cardinal Health 110, LLC. DBA Leader | b1c2055b-4b5a-4fa2-b600-8930c9c8524c | 2026-08-15 | Warnings | M012 |
| Nighttime HBP Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS PHARMACY | 146c9a62-0418-4b5d-9074-5be8a05f3f93 | 2026-08-15 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | 610accad-2f8b-4605-9357-a58e6e18d417 | 2026-08-15 | Warnings | M012 |
| Nasal Decongestant Maximum Strength, Non-Drowsy | PSEUDOEPHEDRINE HCL | Amerisource Bergen | 1fdb1ba5-4072-4baf-9e30-f01d57bf6d82 | 2026-08-15 | Warnings | M012 |
| Cold and Flu Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Walgreen Company | 32c67914-d7cf-40ee-8682-0ba8ed691287 | 2026-08-15 | Warnings | M012 |
| CVS Childrens COLD PLUS COUGH PLUS SORE THROAT | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY | 27820bce-6638-4f17-ac66-62b02b76bec3 | 2026-08-14 | Warnings | M012 |
| CVS PHARMACY Childrens Cold and Allergy | BROMPHENIRAMINE MALEATE | CVS PHARMACY, INC. | 004e104b-d6ff-48d5-8685-cd1bff45399a | 2026-08-14 | Warnings | M012 |
| CHILDRENS DIMETAPP COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS PHARMACY | 7babf4f6-ca0a-44a7-b1ea-d60e20d36f15 | 2026-08-14 | Warnings | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | e7c8ffed-83b8-4088-b72c-d937e93f8b54 | 2026-08-14 | Warnings | M012 |
| CVS Mucus Relief DM and Overnight Cold and Flu | DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN AND TRIPROLIDINE HCL | CVS | 75520b77-d40b-4f43-b92a-7a3eba5b493f | 2026-08-14 | Warnings | M012 |
| CVS Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | CVS PHARMACY | bb24c298-1d00-4378-8de3-b4056220fa75 | 2026-08-14 | Warnings | M012 |
| SEVERE COLD PLUS FLU DAYTIME NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DOXYLAMINE SUCCINATE | CVS Pharmacy,Inc. | 6cb1d08b-e544-4084-b9ed-1e0d99a709c8 | 2026-08-14 | Warnings, Adverse reactions | M012 |
| Theraflu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CVS PHARMACY | 932a3d40-9b52-4e91-bc61-6fd506f2d9e6 | 2026-08-14 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy,Inc. | 91063edd-1e7e-41e9-8412-b14ef3749018 | 2026-08-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 3 |
| 1659967 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 3 |
| 1659967 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Powder for Oral Solution | SY | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 3 |
| 1659967 | APAP 650 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | ebbb2f4b-ba84-40ad-96f6-60225119a33b | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-6800-02 | 00067680002 | 6 POWDER in 1 CARTON (0067-6800-02) | 6 powder | 2022-01-20 | No | No | Current |