Equate Childrens Multi symptom Cold Nighttime
- Product NDC
- 49035-623
- 11-digit product format
- 490350623
- Labeler code
- 49035
- Product ID
- 49035-623_b98874b7-3ef3-4414-b475-0ed764b22aed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Wal-Mart Stores, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-08-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 12.5; 5 mg/10mL; mg/10mL; mg/10mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
- 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
- Equate Childrens Multi symptom Cold Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/10mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 12.5 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1375932 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 49035-623-03 | Equate Childrens Multi symptom Cold Nighttime | 1 in 1 CARTON | LIQUID | 1 | 4 | |
| 49035-623-03 | Equate Childrens Multi symptom Cold Nighttime | 118 mL in 1 BOTTLE | LIQUID | 118 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 49035-623 | EQUATE CHILDRENS MULTI SYMPTOM COLD NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WAL-MART STORES, INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241222_bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee.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 |
|---|---|---|---|---|---|---|
| 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 |
| careone tussin dm | DEXTROMETHORPHAN HBR, GUAIFENESIN | American Sales Company | 6c90fccf-0e6f-43df-9468-d8ece8ded009 | 2024-11-11 | Warnings | M012 |
| good sense night time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | 89dc1423-d097-47a8-9025-eab5381cca26 | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 10f9627b-edda-422a-b01f-7066f9c98335 | 2024-11-11 | Warnings | M012 |
| nighttime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 17c3fe42-3c40-4405-80b7-b3f9e4aa8376 | 2024-11-11 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 1dd36aa7-f085-4350-8cf2-f9fa29b583e4 | 2024-11-11 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | a7f9f1d0-7498-461c-b4e8-4c92cf3feae8 | 2024-11-11 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreen Company | bd079f5d-0a38-40e6-9661-e8236c88a24d | 2024-11-11 | Warnings | M012 |
| GUAIFENESIN DM | GUAIFENESIN AND DEXTROMETHORPHAN | PAI Holdings, LLC dba PAI Pharma | ff970fff-d1a3-4322-83b4-34e361431a1c | 2024-11-11 | Warnings | M012 |
| topcare tussin dm max | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | e1118592-30ac-4505-9f38-c6d395c4cf5b | 2024-11-11 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 624b8029-9fdb-4908-a13b-f9dd75030120 | 2024-11-11 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 4 |
| 2637728 | {1 (acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution) } Pack | GPCK | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution) Pack | PSN | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution | PSN | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1043543 | dextromethorphan HBr 5 MG / guaiFENesin 100 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution | PSN | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | acetaminophen 32.5 MG/ML / diphenhydramine hydrochloride 1.25 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1043543 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 2637728 | 1 daytime (dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution) / 1 nighttime (acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution) Pack | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | APAP 32.5 MG/ML / Diphenhydramine Hydrochloride 1.25 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1375932 | APAP 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1043543 | dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 20 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
| 1043543 | dextromethorphan HBr 5 MG / guaifenesin 100 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Solution | SY | 177e3247-402d-98e4-e063-6294a90ae068 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 49035-623-03 | 49035062303 | 1 BOTTLE in 1 CARTON (49035-623-03) / 118 mL in 1 BOTTLE | 1 bottle | 2017-08-01 | 0000-00-00 | No | No | Current |