Walgreen Childrens
- Product NDC
- 0363-6504
- 11-digit product format
- 003636504
- Labeler code
- 0363
- Product ID
- 0363-6504_447fe94d-279e-8f04-e063-6294a90a26ce
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Dextromethorphan Hydrobromide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- WALGREENS CO.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-24
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 160; 5 mg/5mL; mg/5mL
- Pharmacologic classes
- 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
- Walgreen Childrens
- Brand name suffix
- COLD PLUS COUGH PLUS SORE THROAT
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1370113 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 801880b2-6116-4d26-a7bf-a669eef6ad8b | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-6504-04 | Walgreen ChildrensCOLD PLUS COUGH PLUS SORE THROAT | 120 mL in 1 BOTTLE | SUSPENSION | 120 | 4 | |
| 0363-6504-04 | Walgreen ChildrensCOLD PLUS COUGH PLUS SORE THROAT | 1 in 1 CARTON | SUSPENSION | 1 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-6504 | WALGREEN CHILDRENS COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [WALGREENS CO.] | 3 | Current NDC, 2 package rows | 20241114_801880b2-6116-4d26-a7bf-a669eef6ad8b.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 |
|---|---|---|---|---|---|---|
| AXIV NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 131f6314-c9a1-7af3-e063-6294a90abe6f | 2025-09-17 | Warnings | M012 |
| AXIV DayTime - NightTime 48 Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | VIVUNT PHARMA LLC | 1320e243-344f-98ed-e063-6294a90a0092 | 2025-09-17 | Warnings | M012 |
| AXIV Sinus Severe Mucus | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCLORIDE | VIVUNT PHARMA LLC | 13245298-8b78-e177-e063-6294a90a6bec | 2025-09-17 | Warnings | M012 |
| GoodSense Tussin CF Multi-Symptom Cold, Raspberry | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Geiss, Destin & Dunn Inc. | 3f05cf84-d485-7688-e063-6394a90ae740 | 2025-09-17 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 5d7466b4-fdb7-432b-880d-e7aa4a4acbda | 2025-09-17 | Warnings | M012 |
| allergy relief Childrens | DIPHENHYDRAMINE HCL | United Natural Foods, Inc. dba UNFI | e34d8bf5-e12e-453c-93ea-9c7988c4f13d | 2025-09-16 | Warnings | M012 |
| DayTime Cold Flu Non Drowsy | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Harris Teeter, LLC | 67beb9f6-4e0a-4f7b-b50a-4bcd3a01354f | 2025-09-16 | Warnings | M012 |
| DOMETUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Domel Laboratories | 3ebfc62f-27f6-48b2-9bae-bdefbd1d05fe | 2025-09-16 | Warnings | M012 |
| CareOne Severe Congestion Nasal | OXYMETAZOLINE HYDROCHLORIDE | American Sales Company | d1dba68b-c4e1-4afc-9aee-6a51341b89f5 | 2025-09-16 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | e69ef8dc-09d2-46de-aebf-ba735f4cc7ea | 2025-09-16 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3ea9a1f2-75b3-c67a-e063-6294a90a8caf | 2025-09-13 | Warnings | M012 |
| Menthol Cough Drops Honey Lemon Flavor | MENTHOL HONEY LEMON FLAVOR | CVS Pharmacy | 3eab4cf9-6fdc-a6fb-e063-6394a90a8633 | 2025-09-13 | Warnings | M012 |
| COLD AND FLU DAYTIME-NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORP | 9de9fab3-890a-158d-e053-2a95a90af423 | 2025-09-13 | Warnings | M012 |
| Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Precision Dose, Inc. | 4d0f4f5b-3135-4457-bb8f-ad9d28ca5ea4 | 2025-09-12 | Warnings | M012 |
| Nasal Spray, Circle K | OXYMETAZOLINE HYDROCHLORIDE 0.05% SOLUTION | Lil' Drug Store Products, Inc. | 3ea06e88-a2c6-621b-e063-6294a90a1075 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Harris Teeter, LLC | a0090dc6-0fe5-4ab2-a2cf-6ed19892f363 | 2025-09-12 | Warnings | M012 |
| Multi Symptom Cold and Multi Symptom Nighttime Cold Childrens | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI, ACETAMINOPHEN, DIPHENHYDRAMINE HCI, PHENYLEPHRINE HCI | CVS Pharmacy | ebf2dbb4-96fa-4bf6-9afd-8aa8b5369f2e | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | FSA Store Inc. (Caring Mills) | 8d7bb31b-a47d-4252-a0a7-79d286179fb9 | 2025-09-12 | Warnings | M012 |
| Daytime Nighttime Cold Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 150e5c3a-7c86-4b66-af30-a376df697401 | 2025-09-12 | Warnings | M012 |
| SEVERE COUGH COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 67f8d405-a2ad-4ade-93b4-9b09a0d81d8e | 2025-09-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1370113 | acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension | PSN | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 4 |
| 1370113 | acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension | SCD | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 4 |
| 1370113 | acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension | SY | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 4 |
| 1370113 | APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension | SY | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 4 |
| 1370113 | APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension | SY | 801880b2-6116-4d26-a7bf-a669eef6ad8b | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-6504-04 | 00363650404 | 1 BOTTLE in 1 CARTON (0363-6504-04) / 120 mL in 1 BOTTLE | 1 bottle | 2023-02-24 | No | No | Current |