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 |
|---|---|---|---|---|---|---|
| Basic Care Honey Lemon Cough Drops | MENTHOL | Amazon.com | c0937b13-f679-a764-e053-2a95a90abf89 | 2025-12-05 | Warnings | M012 |
| Basic Care SF Menthol Cough Drops | MENTHOL | Amazon.com | c0946295-7cf0-1bd8-e053-2a95a90af5af | 2025-12-05 | Warnings | M012 |
| Basic Care SF Honey Lemon Cough Drops | MENTHOL | Amazon.com | cf82fb0b-1b4d-def1-e053-2995a90a6fd9 | 2025-12-05 | Warnings | M012 |
| G-DOLOGEN | ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE | Kramer Novis | 7a4e1d64-2510-405f-a1dc-e02a803b6fbd | 2025-12-05 | Warnings | M012 |
| Quality Choice Severe Cold and Cough Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE | Chain Drug Manufacturing Assn | ce658dd5-b683-436e-b16b-0c06f6f87fd9 | 2025-12-04 | Warnings | M012 |
| Quality Choice Maximum Strength | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a87ba15f-b5a9-4983-a721-ca7f705aea86 | 2025-12-04 | Warnings | M012 |
| Quality Choice | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | a12e2e66-d2f3-47a6-a915-a309ae828d27 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus Relief Chest Congestion | GUAIFENESIN | Chain Drug Manufacturing Assn | 034d39c0-9aad-4dff-a158-a041b9f0504f | 2025-12-04 | Warnings | M012 |
| Quality Choice | OXYMETAZOLINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | d01b8fb6-1ddf-4901-bda6-ae608e94a6a4 | 2025-12-04 | Warnings | M012 |
| Childrens Mucus and Cough Relief | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Manufacturing Assn | 06822a28-3f82-471d-8db5-c5981b263a03 | 2025-12-04 | Warnings | M012 |
| QUALITY CHOICE | PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION | 14596551-dd82-46b3-8eb8-e69efaea105b | 2025-12-04 | Warnings | M012 |
| Daytime Cold and Flu Lil Drug Store Products | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc | fd5c20ed-5520-4db0-bfd4-995f043af2a4 | 2025-12-04 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 89c165ba-3ad5-49b5-a5bb-423dc8e15bad | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold Powerfast Fizz Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | a2b30c27-b836-f09f-e053-2995a90ac383 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | a37c9d9d-52db-23ff-e053-2995a90a8f76 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Cough PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a68df74d-dd26-3ae9-e053-2995a90a08d6 | 2025-12-04 | Warnings | M012 |
| Circle K Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 55662ada-677e-4048-9529-5bca44076316 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu | DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | b13d5132-cb91-3cf6-e053-2a95a90aa47c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast Fizz | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | bd97e91f-1ae1-379c-e053-2995a90acfdd | 2025-12-04 | 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 |