COLD AND FLU RELIEF
- Product NDC
- 21130-436
- 11-digit product format
- 211300436
- Labeler code
- 21130
- Product ID
- 21130-436_80e4df04-91c8-4c1b-8092-e5938cdbedc4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Safeway
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-04
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/15mL; mg/15mL; mg/15mL; mg/15mL
- 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
- 2027-12-31
- 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 RELIEF
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/15mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/15mL |
| GUAIFENESIN | 200 mg/15mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/15mL |
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 |
|---|---|
| 1369842 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| d810a6a9-6112-4e9d-a396-36084b7e110e | 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 |
|---|---|---|---|---|---|---|
| 21130-436-40 | COLD AND FLU RELIEF | 355 mL in 1 BOTTLE | SOLUTION | 355 | 2 |
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 |
|---|---|---|---|---|---|---|
| Dollar General | NASAL PHENYLEPHRINE HYDROCHLORIDE | DOLGENCORP, INC. (DOLLAR GENERAL & REXALL) | e8fd3f0e-a023-4423-8906-17ae02bc083b | 2026-09-03 | Warnings | M012 |
| Mucus Relief Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | TARGET Corporation | 1bf9a59e-cc37-4780-ba75-7138c546eb19 | 2026-09-02 | Warnings | M012 |
| Childrens Multi Symptom Fever and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | THE KROGER CO. | 3daf7620-eb57-43d5-ba88-938b7221e346 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | 69fd13a1-2b76-8574-e053-2a91aa0a27e7 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp. | a6880389-0dc1-43a7-a73b-77f77bafe51e | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | fa8510d8-d50a-4743-ba87-a12e9ab43125 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | dfcf1231-8271-458d-b375-e328d6fd4e9b | 2026-09-02 | Warnings | M012 |
| Nighttime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Shield Pharmaceuticals Corp | decafa3a-3734-4161-bab0-121945881846 | 2026-09-02 | Warnings | M012 |
| Kroger Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | KROGER COMPANY | 1ff037ea-1a3b-430a-be31-2e240cc3b6f3 | 2026-09-02 | Warnings | M012 |
| KROGER Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | KROGER COMPANY | 79d24014-1af7-4d62-bcb8-5bea76a7d6ee | 2026-09-02 | Warnings | M012 |
| Kroger No Drip | ALLERGY SINUS | KROGER COMPANY | 4788bafb-8866-4a0a-b217-226513799c24 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | e1d27123-358f-4b0c-8e3b-33474750a0e6 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL | THE KROGER CO | 058b2021-8a61-40b0-8a2e-a784d2b847fb | 2026-09-02 | Warnings | M012 |
| KROGER Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2bea22e9-34b6-4961-94bb-5600dd90e891 | 2026-09-02 | Warnings | M012 |
| KROGER No Drip Nasal Mist Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | KROGER COMPANY | 7256e048-ad69-4322-844d-872f05e6fc8a | 2026-09-02 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | The Kroger Co. | 494e69ef-dc9f-4e14-b856-5eaf0f541a03 | 2026-09-02 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM Sugar Free | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | 5c4c8115-cec9-4f2c-9ea9-328535e97b07 | 2026-09-01 | Warnings | M012 |
| MAX ALLERGY KIDS | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 96c4ade8-67b1-41e5-8624-fb49090208af | 2026-09-01 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | WALMART INC. | 5e6623c3-6210-4c50-94d6-5554f36876d1 | 2026-08-31 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | d810a6a9-6112-4e9d-a396-36084b7e110e | 2 |
| 1369842 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | d810a6a9-6112-4e9d-a396-36084b7e110e | 2 |
| 1369842 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | d810a6a9-6112-4e9d-a396-36084b7e110e | 2 |
| 1369842 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | d810a6a9-6112-4e9d-a396-36084b7e110e | 2 |
| 1369842 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | d810a6a9-6112-4e9d-a396-36084b7e110e | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 21130-436-40 | 21130043640 | 355 mL in 1 BOTTLE (21130-436-40) | 355 ml | 2026-05-04 | No | No | Current |