Nighttime Cold and Flu Relief
- Product NDC
- 69168-418
- 11-digit product format
- 691680418
- Labeler code
- 69168
- Product ID
- 69168-418_1cf8bb4f-4be1-4670-9329-b0eae96944bb
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Allegiant Health
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-11-11
- 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 |
|---|---|
| b97126d7-847d-483e-b3d1-e2b61ab1743f | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69168-418-86 | Daytime Nighttime Cold and Flu Relief Combo Pack | 12 in 1 BLISTER PACK | CAPSULE | 12 | 325 mg | 6 |
| 69168-418-86 | Daytime Nighttime Cold and Flu Relief Combo Pack | 1 in 1 CARTON | CAPSULE | 6.25 mg | 6 | |
| 69168-418-29 | Nighttime Cold and Flu Relief | 8 in 1 BLISTER PACK | CAPSULE | 8 | 5 | |
| 69168-418-51 | Nighttime Cold and Flu Relief | 20 in 1 BLISTER PACK | CAPSULE | 20 | 5 | |
| 69168-418-86 | Daytime and Nighttime Cold and Flu Kit | 1 in 1 CARTON | CAPSULE | 15 mg | 5 | |
| 69168-418-86 | Daytime and Nighttime Cold and Flu Kit | 12 in 1 BLISTER PACK | CAPSULE | 12 | 6.25 mg | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69168-418 | DAYTIME NIGHTTIME COLD AND FLU RELIEF COMBO PACK (DAYTIME NIGHTTIME COLD AND FLU) KIT [ALLEGIANT HEALTH] | 5 | Current NDC, Legacy NDC | 20231020_fa7ed5db-4da7-46b4-a08d-1d79cb7a5674.zip |
| 69168-418 | NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN) CAPSULE [ALLEGIANT HEALTH] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231116_b97126d7-847d-483e-b3d1-e2b61ab1743f.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 |
|---|---|---|---|---|---|---|
| Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE | Topco Associates LLC | a2929bcb-fa81-4f15-b087-a9996b5e7d1f | 2024-11-13 | Warnings | M012 |
| Equate Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Walmart | 6271bb48-74b2-eb57-e053-2991aa0afd1b | 2024-11-13 | Warnings | M012 |
| Equaline Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | United Natural Foods, Inc. dba UNFI | 6bf341e0-94b1-08ff-e053-2991aa0af634 | 2024-11-13 | Warnings | M012 |
| Good Sense Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Good Sense | cd25e250-bb8b-7e83-e053-2a95a90a2639 | 2024-11-13 | Warnings | M012 |
| Top Value Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Tower Laboratories Ltd | 440a00b1-7960-0cc4-e054-00144ff8d46c | 2024-11-13 | Warnings | M012 |
| Top Value Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Tower Laboratories Ltd. | c6f207e8-bc0d-853a-e053-2a95a90ac623 | 2024-11-13 | Warnings | M012 |
| Effervescent Orange Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | DOLGENCORP, LLC | 7fad8e65-34fe-5313-e053-2a91aa0a56f4 | 2024-11-13 | Warnings | M012 |
| Dollar General Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHYLEPHRINE BITARTRATE | DOLGENCORP, LLC | 7face5c7-f5c7-7eee-e053-2991aa0ab064 | 2024-11-13 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 90622927-9682-4eb0-8c7f-894230b3dda4 | 2024-11-13 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 9f7d76f0-4f1c-a1c7-e053-2a95a90a3dca | 2024-11-13 | Warnings | M012 |
| WinCo Foods Effervescent Cold Relief | ASPIRIN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE BITARTRATE | WinCo Foods, LLC | d443a030-d3d6-40e0-8fe0-329de6bc494f | 2024-11-13 | Warnings | M012 |
| careone tussin dm | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | 954fe703-9a10-4354-8b71-4d98a22a0b9f | 2024-11-13 | Warnings | M012 |
| NASAL DECONGESTANT PE | PHENYLEPHRINE HCL | A-S Medication Solutions | 9d030767-dfd6-48b4-9b17-4e20c23915f3 | 2024-11-13 | Warnings | M012 |
| Childrens SUDAFED PE Cold plus Cough | DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Kenvue Brands LLC | 20e45243-3989-413a-bcf1-49d754ff2e44 | 2024-11-12 | Warnings | M012 |
| Tukol Cough And Cold Honey Flavor | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | a4b333dc-58da-45db-87b6-6fcb8fb542b8 | 2024-11-12 | Warnings | M012 |
| daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 4b49137c-8fc9-43b7-b1a1-82e318237eb6 | 2024-11-12 | Warnings | M012 |
| CVS Original Nasal Mist | OXYMETAZOLINE HCL | CVS PHARMACY, INC | e9c551a0-cd78-4272-b42f-36c096d26736 | 2024-11-12 | Warnings | M012 |
| up and up cough plus chest congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Target Corporation | ed5dfeb1-8f7a-46ff-ae27-3fa5de5b397c | 2024-11-12 | Warnings | M012 |
| DG Health Cold and Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | b33d104b-0b4d-40c6-8345-c2c740327331 | 2024-11-11 | Warnings | M012 |
| Zephrex D | PSEUDOEPHEDRINE HYDROCHLORIDE | L. Perrigo Company | 5468a7e2-361b-494f-9ca3-1b62f3819f65 | 2024-11-11 | 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 | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 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 | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 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 | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | fa7ed5db-4da7-46b4-a08d-1d79cb7a5674 | 6 |
| 2676954 | {1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } Pack | GPCK | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Capsule | SCD | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 2676954 | 1 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) Pack | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1867684 | APAP 325 MG / Dextromethorphan Hydrobromide 10 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | b97126d7-847d-483e-b3d1-e2b61ab1743f | 5 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 0533db78-7809-46ea-9998-deb5f6f1d0d9 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69168-418-29 | 69168041829 | 8 CAPSULE in 1 BLISTER PACK (69168-418-29) | 8 capsule | 2020-11-11 | 0000-00-00 | No | No | Current |
| 69168-418-51 | 69168041851 | 20 CAPSULE in 1 BLISTER PACK (69168-418-51) | 20 capsule | 2020-11-11 | 0000-00-00 | No | No | Current |
| 69168-418-86 | 69168041886 | 12 in 1 BLISTER PACK | Historical |