Nighttime Cold and Flu Relief
- Product NDC
- 21130-899
- 11-digit product format
- 211300899
- Labeler code
- 21130
- Product ID
- 21130-899_5cbccb36-9354-490c-b2c2-73b9c4dfd586
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- Safeway, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-11-29
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
- Active strength
- 325; 15; 6.25 mg/1; mg/1; mg/1
- Pharmacologic classes
- Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- 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
- Nighttime Cold and Flu Relief
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
| DOXYLAMINE SUCCINATE | 6.25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| V9BI9B5YI2 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1094549 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21130-899-24 | Nighttime Cold and Flu Relief | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | 5 | |
| 21130-899-24 | Nighttime Cold and Flu Relief | 24 in 1 CARTON | CAPSULE, LIQUID FILLED | 24 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21130-899 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [SAFEWAY, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241116_45d44cd2-5187-4a5c-983a-edb1e8eba0b2.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 |
|---|---|---|---|---|---|---|
| COLD MAX | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | a1aba467-c91f-4812-b0b9-ff5fdfa298e3 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e3dd12f1-dd63-27ae-e053-2995a90aaaeb | 2024-10-17 | Warnings | M012 |
| COLD and FLU SEVERE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | e44ac549-3e9b-4271-a2b2-ecb124f79832 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | f171a389-8b22-429c-86bc-272156fdc1b7 | 2024-10-17 | Warnings | M012 |
| Daytime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | 6c5b5427-e47a-4eff-928a-c891452facf9 | 2024-10-17 | Warnings | M012 |
| COLD AND FLU SEVERE | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | ddeb8978-84b6-4a19-b25e-99d1c29e58d9 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold and Flu All in One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20baef9-6e68-6679-e053-2a95a90a2b63 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20b71fb-8787-c871-e053-2a95a90a8eb4 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DISCOUNT DRUG MART | b20bc492-fed3-bf05-e053-2a95a90ad393 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | a4d6ecb9-ea67-41ed-917b-9bb4d1e50551 | 2024-10-17 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 08fda81a-bedd-4ff3-9c32-2066d2cea3f9 | 2024-10-17 | Warnings | M012 |
| Guaifenesin | GUAIFENESIN | American Health Packaging | 2fd702ea-3069-472c-b99e-c527f1375705 | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Selder, S.A. de C.V. | c2b49d10-b60f-3072-e053-2a95a90af004 | 2024-10-17 | Warnings | M012 |
| Head Congestion plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | United Natural Foods, Inc. dba UNFI | 1db914d3-8bba-405e-9bf9-9b1a5806284c | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | e2c35fae-9dd6-51f2-e053-2995a90a1e9e | 2024-10-17 | Warnings | M012 |
| Cough and Cold XL3 Xtra | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE DEXTROMETHORPHAN HYDROBROMIDE PHENYLEPHERINE HYDROCHLORIDE | Selder, S.A. de C.V. | da5b31dd-becd-471a-9392-d0ee4b8f9539 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 FORTE | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | MIDWAY IMPORTING INC. | 58252f15-485c-3061-e053-2a91aa0a2320 | 2024-10-17 | Warnings | M012 |
| Cold Medicine XL3 | ACETAMINOPHEN CHLORPHENIRAMINE MALEATE PHENYLEPHERINE HYDROCHLORIDE | Midway Importing, Inc. | e41b9beb-e274-5c02-e053-2995a90ad0f8 | 2024-10-17 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | STRATEGIC SOURCING SERVICES LLC | 38e70a28-eff2-4a48-b829-8cd68e80beef | 2024-10-17 | Warnings | M012 |
| Mucus Relief Xpect | GUAIFENSIN, DEXTROMETHORPHAN | Midway Importing Inc. | c2c8bd26-bbf1-c2e6-e053-2995a90a86a7 | 2024-10-17 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2634564 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 2634564 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 764bcc58-bc5f-4ee6-82b7-cb0ed5baf3be | 8 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 45d44cd2-5187-4a5c-983a-edb1e8eba0b2 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 21130-899-24 | 21130089924 | 24 BLISTER PACK in 1 CARTON (21130-899-24) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 24 blister pack | 2019-11-29 | 0000-00-00 | No | No | Current |