Kroger NightTime Cold and Flu SOFTGEL
- Product NDC
- 59450-047
- 11-digit product format
- 594500047
- Labeler code
- 59450
- Product ID
- 59450-047_fb4c197e-d90f-43f0-a8db-b997b4748371
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- The Kroger Co.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-08
- 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
- 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
- Kroger NightTime Cold and Flu SOFTGEL
- Listing expiration
- 2026-12-31
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 |
|---|---|
| 24a73de3-e9eb-4cd4-e063-6394a90aa263 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59450-047-48 | Kroger NightTime Cold and Flu SOFTGEL | 12 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 12 | 2 | |
| 59450-047-48 | Kroger NightTime Cold and Flu SOFTGEL | 4 in 1 CARTON | CAPSULE, LIQUID FILLED | 4 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59450-047 | KROGER NIGHTTIME COLD AND FLU SOFTGEL (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE KROGER CO.] | 2 | Current NDC, 2 package rows | 20250123_24a73de3-e9eb-4cd4-e063-6394a90aa263.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 |
|---|---|---|---|---|---|---|
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 770c0e4f-0eed-4b8c-85a5-761b6a84db62 | 2025-12-02 | Warnings | M012 |
| Multi Symptom Severe Cold and Nighttime Severe Cold and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | WAL-MART STORES INC | a2a7e568-bff8-4818-a31d-7c2efa1859c3 | 2025-12-02 | Warnings | M012 |
| DayTime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET, FILM COATED TABLET | Lil' Drug Store Products, Inc. | 44fa0193-2a19-bdc1-e063-6394a90a60e8 | 2025-12-02 | Warnings | M012 |
| Nighttime Severe, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL TABLET, FILM COATED | Lil' Drug Store Products, Inc. | 44fb9958-d771-f4b3-e063-6294a90a9135 | 2025-12-02 | Warnings | M012 |
| Quality Choice Mucus Relief | GUAIFENESIN | Chain Drug Marketing Association | f1a73da7-0dbb-49bd-857e-7dd6bc11b63c | 2025-12-02 | Warnings | M012 |
| Cold and Flu Relief Daytime | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CARDINAL HEALTH 110, LLC. DBA LEADER 70000 | ac74be47-30f0-418b-bd07-502feaa9723f | 2025-12-01 | Warnings | M012 |
| Walgreens High Blood Pressure Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN | WALGREENS CO. | bc83b55e-c3d8-460f-8ef9-ff7b2e4f7272 | 2025-12-01 | Warnings | M012 |
| Walgreen High Blood Pressure Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | WALGREENS CO. | f1b7b58f-bbc3-441f-926f-d66e6a9b4e3a | 2025-12-01 | Warnings | M012 |
| Walgreens Nighttime Kids Honey Cold Cough Congestion | DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO | c0f317cd-723d-47f2-b600-aaeae6399482 | 2025-12-01 | Warnings | M012 |
| Walgreen Maximum Strength Severe Congestion and cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALGREENS CO. | b4abcb6d-f3e1-4d63-98cf-ff556ec423b6 | 2025-12-01 | Warnings | M012 |
| Walgreens Daytime Childrens | COUGH AND CHEST CONGESTION | WALGREENS CO. | dd99675f-3860-42ef-999c-d9a3746a38c0 | 2025-12-01 | Warnings | M012 |
| Adult Cough plus Chest Congestion DM with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | WALGREEN COMPANY | 5f5af13a-c2a3-4bbe-880e-9c57b36e9234 | 2025-12-01 | Warnings | M012 |
| Walgreens Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREEN COMPANY | b2e08f4d-9753-4767-a8eb-3740dd1034cc | 2025-12-01 | Warnings | M012 |
| WALGREENS Cold Cough and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | WALGREENS CO. | 1e903034-942e-4c6e-9f96-eb097c266580 | 2025-12-01 | Warnings | M012 |
| Walgreens DAY and NIGHT PACK | DEXTROMETHORPHAN HBR, GUAIFENESIN, CHLORPHENIRAMINE MALEATE | WALGREEN CO | cb87e57b-ff06-4973-9751-137c7021e272 | 2025-12-01 | Warnings | M012 |
| WALGREEN Multi Symptom Flu Relief Combo Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | WALGREENS CO. | b7b1d604-921d-4ae7-93de-dcf690d421b4 | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Meijer Distribution Inc | 235b2866-bbda-7148-e063-6394a90a898f | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | Whole Foods Market, INC. | 32352109-31dc-8e6f-e063-6294a90a2f92 | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | BIONPHARMA INC. | 323347c3-d51a-4976-e063-6294a90a952e | 2025-12-01 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | WALGREEN COMPANY | 2969ba8f-c477-222a-e063-6394a90af703 | 2025-12-01 | 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 | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 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 | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule | PSN | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule | PSN | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1086997 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SCD | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2 |
| 1094549 | acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SCD | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 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 | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1086997 | APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule | SY | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | 24a73de3-e9eb-4cd4-e063-6394a90aa263 | 2 |
| 1094549 | APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule | SY | a11d3a31-2c72-40c2-bd78-dd93903b8daf | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 59450-047-48 | 59450004748 | 4 BLISTER PACK in 1 CARTON (59450-047-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 4 blister pack | 2025-01-08 | No | No | Current |