Cold and Flu
- Product NDC
- 11822-5031
- 11-digit product format
- 118225031
- Labeler code
- 11822
- Product ID
- 11822-5031_9bb89fcc-766f-491d-8d7d-9e4984bbce2b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rite Aid Corporation
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-08-04
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cold and Flu
- Brand name suffix
- 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 Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1110988 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-5031-8 | Cold and FluSevere | 2 in 1 CARTON | TABLET, FILM COATED | 2 | 16 | |
| 11822-5031-8 | Cold and FluSevere | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11822-5031 | COLD AND FLU SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] | 15 | Current NDC, Legacy NDC, 2 package rows | 20241113_1affbef6-dd27-40c2-a5d3-b121aa62496a.zip |
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 | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 16 |
| 1110988 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SCD | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 16 |
| 1110988 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Tablet | SY | 1affbef6-dd27-40c2-a5d3-b121aa62496a | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11822-5031-8 | 11822503108 | 2 BLISTER PACK in 1 CARTON (11822-5031-8) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2005-08-04 | 0000-00-00 | No | No | Current |