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 |
|---|---|---|---|---|---|---|
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 4c3d57e3-e40b-41ca-b44b-5f4c5f4dbae5 | 2024-04-06 | Warnings | M012 |
| DEXTROMETHORPHAN HBR, GUAIFENESIN | DEXTROMETHORPHAN HBR, GUAIFENESIN | OPMX LLC | 9a16e7f3-78aa-0b01-e053-2a95a90ab19c | 2024-04-05 | Warnings | M012 |
| Theraflu Severe Cold Relief Daytime Honey Ginger | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 44404c6a-8031-4f4b-a48e-3739a11a0d2c | 2024-04-05 | Warnings | M012 |
| Activcin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | e06a4d72-cc8d-fd9d-e053-2995a90a7a76 | 2024-04-05 | Warnings | M012 |
| Coldtac Plus Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5ce5c6-a03f-2ad3-e053-6394a90a99f6 | 2024-04-05 | Warnings | M012 |
| Desresfriol-DX Softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | OPMX LLC. | ff5e0e0f-bfd2-b02b-e053-6394a90afe8a | 2024-04-05 | Warnings | M012 |
| Leader Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | Cardinal Health 110,Inc | 98bf8e84-b555-4b5a-90a0-7837a5560289 | 2024-04-03 | Warnings | M012 |
| DAYTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Advanced Rx LLC | 38299cf3-e884-4676-8cc4-6dd64e7d023c | 2024-03-30 | Warnings | M012 |
| NIGHTTIME COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | Advanced Rx LLC | d1542362-19c5-4470-89e8-87d26e2ca8ed | 2024-03-30 | Warnings | M012 |
| ANTIGRIP Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Pharmadel LLC | 12de30fd-95b6-f16d-e063-6294a90aeba2 | 2024-03-27 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Family Dollar (FAMILY WELLNESS) | 0044c53c-11dd-41a9-a5d9-622dd8b1c144 | 2024-03-27 | Warnings | M012 |
| Codeine-Guaifenesin | CODEINE PHOSPHATE AND GUAIFENESIN | Bryant Ranch Prepack | 9812056b-736e-40c5-ae60-21dd9221397c | 2024-03-22 | Warnings | M012 |
| Tussin CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Best Choice (Valu Merchandisers Company) | 1b7b5811-722e-4c4a-844d-c05fa5cfb2e5 | 2024-03-21 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2a77c3-7d0f-157b-e053-2995a90a951a | 2024-03-19 | Warnings | M012 |
| Robitussin Medi-Soothers | DEXTROMETHORPHAN HYDROBROMIDE, MENTHOL | Haleon US Holdings LLC | 6bec225e-a203-4866-b0db-b76f73a6ae25 | 2024-03-19 | Warnings | M012 |
| Cold and Flu Relief Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 06d47104-a8ca-48cc-b27e-08c9d018c37b | 2024-03-19 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | b80dae7f-ed2d-4a9e-bef9-f1ed8add0174 | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | WALGREENS | c945c35e-de0d-0fd6-e053-2995a90a1fbf | 2024-03-19 | Warnings | M012 |
| Daytime Nighttime Sinus Relief Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL/ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE,PHENYLEPHRINE HCL | Walgreens | da046b01-707c-326a-e053-2995a90a0927 | 2024-03-19 | Warnings | M012 |
| DAYTIME NIGHTTIME SEVERE COLD AND FLU Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR,GUAIFENESIN, PHENYLEPHRINE HCL / ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreens | da2b0276-9ab0-38e6-e053-2a95a90a54d8 | 2024-03-19 | 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 |