Cold Flu Severe
- Product NDC
- 37808-663
- 11-digit product format
- 378080663
- Labeler code
- 37808
- Product ID
- 37808-663_25004366-2824-caf8-e063-6394a90a9c14
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- HEB
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-05-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Cold Flu Severe
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 495W7451VQ | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1110988 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ea39a67d-8a99-4f7c-9925-94b07d0b1092 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 37808-663-05 | Cold Flu Severe | 2 in 1 CARTON | TABLET, COATED | 2 | 4 | |
| 37808-663-05 | Cold Flu Severe | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 37808-663 | COLD FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [HEB] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241023_ea39a67d-8a99-4f7c-9925-94b07d0b1092.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 |
|---|---|---|---|---|---|---|
| childrens Allergy Dye Free Wal Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 4e64e040-1662-4dc9-b33f-3e119e0b3f7b | 2025-11-25 | Warnings | M012 |
| Walgreen | NASAL | WALGREENS CO | d38f8406-d7b9-472c-a472-58968bbdb993 | 2025-11-25 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 2025-11-25 | Warnings | M012 |
| Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | d13efbcd-1277-45d0-8389-1ba0337f7a24 | 2025-11-25 | Warnings | M012 |
| Childrens Robitussin Elderberry Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | fe903448-b422-42e0-b05b-aeb3e5481e3c | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 1d4fcb76-22d1-7292-e063-6394a90af920 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | f22248b7-7abd-4df7-a986-dae357ebe8f1 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN Nighttime Cough DM Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 39468746-e06d-4849-9d06-9af4d14351b0 | 2025-11-25 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 4478fd51-bae3-6108-e063-6394a90a07ca | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC. | 395bb39a-e26f-f4f2-e063-6394a90ae721 | 2025-11-25 | Warnings | M012 |
| day time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | eaf3af6a-de5b-43fe-83ff-9641646e0f6b | 2025-11-25 | Warnings | M012 |
| MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | RB Health (US) LLC | 38571853-992f-9998-e063-6394a90a8581 | 2025-11-24 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | e19b561c-fb76-4355-a306-d3dc46930bf2 | 2025-11-24 | Warnings | M012 |
| Sinus Decongestion | PSEUDOEPHEDRINE HCL | Kroger Company | 73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c | 2025-11-24 | Warnings | M012 |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Cardinal Health (Leader) 70000 | 14c507df-fbac-4a09-a66c-b91c2abbf550 | 2025-11-24 | Warnings | M012 |
| Severe Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI | Family Dollar (FAMILY WELLNESS) | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 2025-11-24 | Warnings | M012 |
| Throat Coat Eucalyptus Mint | MENTHOL | Traditional Medicinals, Inc. | a7a86f1b-30e8-6f5d-e053-2a95a90a2a82 | 2025-11-21 | Warnings | M012 |
| Throat Coat Sweet Orange Fennel | MENTHOL | Traditional Medicinals, Inc. | 4538248f-11cc-d6b2-e063-6294a90a652c | 2025-11-21 | Warnings | M012 |
| up and up Daytime Nighttime Childrens Multi Symptom Cold | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | b8a4da0b-e4d3-48e6-b699-cb56c7b67ed7 | 2025-11-20 | Warnings | M012 |
| Supress DX Pediatric Drops | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | ddb95436-7806-4086-af4d-18a6625b5c83 | 2025-11-20 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1110988 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Tablet | PSN | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 4 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 4 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | ea39a67d-8a99-4f7c-9925-94b07d0b1092 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 37808-663-05 | 37808066305 | 2 BLISTER PACK in 1 CARTON (37808-663-05) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2018-05-01 | 0000-00-00 | No | No | Current |