NDC 68210-5053-01 - Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 68210-5053
- Requested NDC
- 68210-5053-01
- Package NDCs from labels
- 68210-5053-1, 68210-5053-01
- Manufacturer
- Prodose, Inc.
- Effective date
- 2026-07-24
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE - Prodose, Inc. | Prodose, Inc. | 2026-07-24 | HUMAN OTC DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68210-5053-1 | Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | 3000 in 1 POUCH | CAPSULE, LIQUID FILLED | 3000 | 2 | |
| 68210-5053-1 | Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 2 |
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 |
|---|---|---|---|---|---|---|
| MAX ALLERGY KIDS | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 96c4ade8-67b1-41e5-8624-fb49090208af | 2026-09-01 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | M012 |
| Lidocaine Phenylephrine | LIDOCAINE PHENYLEPHRINE | YYBA CORP | 5a72a190-2129-411e-e063-6394a90a08c2 | 2026-09-01 | Warnings | 04JA59TNSJ |
| Kroger Children Pain plus Fever chewables | ACETAMINOPHEN | KROGER COMPANY | 83b5733c-70a1-4383-9729-2eb896d0149a | 2026-09-01 | Warnings | 362O9ITL9D |
| Pain Reliever PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | TOP CARE (Topco Associates LLC) | 923b443d-73cc-4c52-92e4-a075786b1ae3 | 2026-09-01 | Warnings | 362O9ITL9D |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | WALMART INC. | 5e6623c3-6210-4c50-94d6-5554f36876d1 | 2026-08-31 | Warnings | M012 |
| WALMART DAYTIME AND NIGHTTIME MS SEVERE RELIEF VALUE PACK | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL | WAL-MART STORES INC | 888bd90a-a059-4814-bd65-6b735ecfaf3a | 2026-08-31 | Warnings | M012 |
| ACETAMINOPHEN PM | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | Amazon.com Services LLC | 99a137d6-07eb-43bc-b4b4-1a23041d595e | 2026-08-31 | Warnings | 362O9ITL9D |
| Acetaminophen Extra Strength | ACETAMINOPHEN | CVS PHARMACY | 64a1ebe7-af28-4b09-96e8-28fa4dcc52bd | 2026-08-31 | Warnings | 362O9ITL9D |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-08-31 | Warnings | M012 |
| equate daytime nighttime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESEN, PHENYLEPHRINE HYDROCHLORIDE | Sixarp, LLC | 5a5a6917-9fb5-e6ca-e063-6394a90af9dc | 2026-08-31 | Warnings | M012 |
| Zicam Intense Sinus Relief | OXYMETAZOLINE HYDROCHLORIDE | Church & Dwight Co., Inc. | d916f7ff-84b7-57ef-e053-2995a90a3efa | 2026-08-31 | Warnings | M012 |
| Afrin Original Nasal | OXYMETAZOLINE HYDROCHLORIDE | JC World Bell Wholesale Co., Inc. | ecfa14b8-a3f3-4569-b489-c9e1a51cf09e | 2026-08-31 | Warnings | M012 |
| Dextromethorphan HBr | DEXTROMETHORPHAN HBR | BIONPHARMA INC. | 5a5dde85-8785-8149-e063-6294a90a4d57 | 2026-08-31 | Warnings | M012 9D2RTI9KYH |
| Equate Nasal | OXYMETAZOLINE HCL | Sixarp, LLC | 5a5e2458-bab0-4931-e063-6394a90ad606 | 2026-08-31 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH RELIEF | DEXTROMETHORPHAN HYDROBROMIDE AND HEXYLRESORCINOL | Reckitt Benckiser LLC | 8d670d91-9e22-45b9-b568-5b62c2133d32 | 2026-08-31 | Warnings | M012 9D2RTI9KYH |
| Daytime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | e85b4c2a-d4e0-452c-9a08-fcc0ff6eaa21 | 2026-08-31 | Warnings | M012 1086997 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | Akron Pharma Inc. | cc769c26-556a-4831-bd75-61a7383aa707 | 2026-08-31 | Warnings | 362O9ITL9D |
| MAX relief junior | CHILDRENS ACETAMINOPHEN | Akron Pharma Inc. | ebb3b4ba-2d0b-48d9-b6ee-6d4696aea047 | 2026-08-31 | Warnings | 362O9ITL9D |
| Daytime Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 67849e09-2056-4013-98b1-d003ed3250a2 | 2026-08-31 | Warnings | M012 1086997 9D2RTI9KYH 04JA59TNSJ 362O9ITL9D |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.