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 |
|---|---|---|---|---|---|---|
| THERAFLU NIGHTTIME SEVERE COLD AND COUGH | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Haleon US Holdings LLC | 5f7f6f70-0f36-4541-89f2-d953259cdb1e | 2024-01-28 | Warnings | M012 |
| RESFRIOL D | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | 0e9c96b9-41ac-0faf-e063-6294a90a8ab5 | 2024-01-26 | Warnings | M012 |
| Allergy Relief | ALLERGY RELIEF | Good Sense | bb709377-7bb3-4931-a2b6-2443aee07c12 | 2024-01-26 | Warnings | M012 |
| Robitussin Maximum Strength Severe Multi-Symptom Cough Cold Flu Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Haleon US Holdings LLC | 721bfee2-0d3d-4d8b-beee-1ea83064d1c8 | 2024-01-23 | Warnings | M012 |
| Sugar Free Cough Drops Honey Lemon | MENTHOL | Cardinal Health 110, Inc. | fe90dc33-2815-8296-e053-6294a90ac1df | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops | MENTHOL | Cardinal Health 110, Inc. | fe91543e-a798-6399-e053-6394a90af5e5 | 2024-01-19 | Warnings | M012 |
| Sugar Free Cough Drops Black Cherry | MENTHOL | Cardinal Health 110, Inc. | fe90cf63-d286-fa5e-e053-6394a90a7759 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol Honey Lemon | COUGH DROPS MENTHOL | Cardinal Health 110, Inc. | fe5b3f6d-2a2d-f322-e053-6394a90aba04 | 2024-01-19 | Warnings | M012 |
| Cough Drops Menthol | MENTHOL COUGH DROPS | Cardinal Health 110, Inc. | fe5b557e-a689-a32c-e053-6294a90aadbd | 2024-01-19 | Warnings | M012 |
| Cough Drops Cherry | CHERRY FLAVOR COUGH DROPS | Cardinal Health 110, Inc. | fe5b5e57-1368-c62b-e053-6294a90ae82c | 2024-01-19 | Warnings | M012 |
| Leader Zinc Oxide | ZINC OXIDE | Cardinal Health 110,Inc. | 4d675dfd-6ea9-4aa7-a4ff-bb84f87ff7d1 | 2024-01-18 | Warnings | M012 |
| Cough and Congestion DM Sugar Free | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Best Choice (Valu Merchandisers Company) | 4656e60e-4733-45c1-bf55-d156e45085c6 | 2024-01-17 | Warnings | M012 |
| Nasal Decongestant | PSEUDOEPHEDRINE HCL | Rugby Laboratories | 775f97c0-6f82-49a8-82ac-f1a73920c3ec | 2024-01-11 | Warnings | M012 |
| SinuFrin NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | f9ec6ac3-1e00-4e97-97c8-b2cd66a752ae | 2024-01-11 | Warnings | M012 |
| SinuFrin Plus NeilMed | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals, Inc. | 99afe6a6-1350-49c6-9347-b7e531e35925 | 2024-01-11 | Warnings | M012 |
| Childrens Tukol Multi-Symptom Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | 85fe6f0f-41c8-44d3-a34a-355938da5f72 | 2024-01-11 | Warnings | M012 |
| Allergy Relief Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cardinal Health 110, LLC. DBA Leader | ad437177-08eb-4811-883f-ac543d5bc58c | 2024-01-11 | Warnings | M012 |
| Allergy Antihistamine | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | af5053d8-ba02-4cdf-877f-8c1e368dafe0 | 2024-01-10 | Warnings | M012 |
| HISTEX | TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | cc466d33-cf3e-4f1c-a794-6d3d79903adf | 2024-01-08 | Warnings | M012 |
| HISTEX-DM | DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Allegis Pharmaceuticals, LLC | 836d062c-29f0-4fd7-b65c-771a3bbd52c4 | 2024-01-08 | 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 |