COLD AND FLU SEVERE
- Product NDC
- 36800-502
- 11-digit product format
- 368000502
- Labeler code
- 36800
- Product ID
- 36800-502_285fe81c-affe-826a-e063-6394a90abd0a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- TOPCARE
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-01
- 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 AND 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 |
|---|---|
| cbb179c8-31fb-4a3a-9f23-4024350f8b7f | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 36800-502-05 | COLD AND FLU SEVERE | 12 in 1 BLISTER PACK | TABLET, COATED | 12 | 5 | |
| 36800-502-05 | COLD AND FLU SEVERE | 2 in 1 CARTON | TABLET, COATED | 2 | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36800-502 | COLD AND FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [TOPCARE] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241206_cbb179c8-31fb-4a3a-9f23-4024350f8b7f.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 |
|---|---|---|---|---|---|---|
| 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 |
| Cough Drops Gems Flawless Cherry Flavor 30ct | MENTHOL | Riclan S.A. | 0f0260df-89ac-4b83-afea-3aff56ff1b43 | 2025-11-18 | Warnings | M012 |
| Cough Drops Gems Flawless Honey Lemon Flavor 30ct | MENTHOL | Riclan S.A. | 16f6d531-9298-4172-8d08-ecd87d6add76 | 2025-11-18 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Haleon US Holdings LLC | a6f750c8-8738-4965-a3ad-612c24611056 | 2025-11-18 | Warnings | M012 |
| YINCHIAO | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | 09ba45f6-03e1-46b9-83ab-a618b2626716 | 2025-11-18 | Warnings | M012 |
| GANMAOLING | ACETAMINOPHEN AND CHLORPHENIRAMINE MALEATE | ANHUI DONGSHENGYOUBANG PHARMACEUTICAL CO., LTD. | c757a03e-59ea-469c-970d-4bc62e73f36f | 2025-11-18 | Warnings | M012 |
| M-Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | Bryant Ranch Prepack | e1d545dc-9222-4d61-964d-1c781215d7d2 | 2025-11-18 | Warnings | M012 |
| Goodnow cold flu day relief cold flu night relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Gobrands, Inc | 7590d0c6-121e-4016-b6bb-534c5d0a7970 | 2025-11-17 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | R J General Corporation | d786ae07-ce57-44c7-9ba5-f4c87df115de | 2025-11-17 | Warnings | M012 |
| Benadryl Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | R J General Corporation | c46c01c0-29f4-400c-bef5-14b3eb944c51 | 2025-11-17 | Warnings | M012 |
| TYLENOL COLD AND FLU | ACETAMINPHEN | R J General Corporation | b618877b-9dbc-4ba2-be2c-bf1922c646cc | 2025-11-17 | Warnings | M012 |
| TYLENOL SINUS SEVERE | ACETAMINOPHEN | R J General Corporation | 2cbf7954-b28f-4d7b-b142-6c6c5c58b25d | 2025-11-17 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | R J General Corporation | 8f0e4876-6bf0-4f6d-9cf0-f2aef2682ffc | 2025-11-17 | Warnings | M012 |
| Quality Choice Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | QUALITY CHOICE (Chain Drug Marketing Association) | c0e3c959-bed6-2ce5-e053-2995a90a0be9 | 2025-11-17 | Warnings | M012 |
| MUCUS RELIEF | GUAIFENESIN | Geri-Care Pharmaceuticals, Corp | c5ea5a7a-c806-e5e0-e053-2995a90a15e9 | 2025-11-17 | Warnings | M012 |
| Multi-Symptom Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 50f3157b-5788-4b63-835a-e60c8dc33df9 | 2025-11-17 | Warnings | M012 |
| Day and Night Sinus | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | a9d809f5-63a1-4f80-8b4d-33e8e052c7bd | 2025-11-15 | Warnings | M012 |
| Cold and Flu Day, Night | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 937b481a-e0b7-4d34-a8a1-0bfb2b867c2b | 2025-11-15 | Warnings | M012 |
| Sinus Pressure, Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | f701a6ae-200d-48dc-94e4-6bd3228f50d4 | 2025-11-15 | 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 | cbb179c8-31fb-4a3a-9f23-4024350f8b7f | 5 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | cbb179c8-31fb-4a3a-9f23-4024350f8b7f | 5 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | cbb179c8-31fb-4a3a-9f23-4024350f8b7f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 36800-502-05 | 36800050205 | 2 BLISTER PACK in 1 CARTON (36800-502-05) / 12 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2013-07-01 | 0000-00-00 | No | No | Current |