Over-the-counter drug · OTC MONOGRAPH NOT FINAL
Acetaminophen Diphenhydramine HCl NDC 68016-654
Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 · Tablet · Oral · Chain Drug Consortium,LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68016-654-05 | 68016065405 | 50 TABLET in 1 BOTTLE (68016-654-05)Marketed from Feb 25, 2016 | |
| 68016-654-10 | 68016065410 | 100 TABLET in 1 BOTTLE (68016-654-10)Marketed from Feb 25, 2016 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Acetaminophen Diphenhydramine HCl
- Generic name (nonproprietary)
- acetaminophen diphenhydramine hcl
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Chain Drug Consortium,LLC
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph (not final)Application part343
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 68016-654_47f839b9-ac8b-161c-e054-00144ff8d46cSPL ID 47f839b9-ac8b-161c-e054-00144ff8d46cSPL set ID 47f839b9-ac8a-161c-e054-00144ff8d46cRxCUI 1092189UNII 362O9ITL9D, 8GTS82S83MUPC 0840986031847, 0840986031830
- Pharmacologic class
- Histamine-1 Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N468016065405followed by a unit qualifier and the quantityPackage 68016-0654-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
Other NDCs under part343
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Broncochem Expectorant IIacetaminophen-chlorpheniramine maleate-dextromethorphan hbr-guaifenesin-phenylephrine hcl | Acetaminophen 250 mg/10mL + 4 more ingredients | SyrupOral | LABORATORIO MAGNACHEM INTERNATIONAL SRL | 65131-116 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | PuraCap Pharmaceutical LLC | 51013-320 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-034 |
| Doans Extra Strengthmagnesium salicylate | Magnesium salicylate 580 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 55741-224 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-040 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc | 54738-111 |
| Chewable Acetaminophen Childrensacetaminophen | Acetaminophen 80 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-092 |
| Extra Strength Acetaminophenacetaminophen | Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS PHARMACY, INC. | 69842-390 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-540 |
| Aspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Richmond Pharmaceuticals, Inc. | 54738-128 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-541 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-548 |
| Aspirin | Aspirin 81 mg/1 | TabletOral | Richmond Pharmaceuticals, Inc. | 54738-559 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-001 |
| Acetaminophen Capletsacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Breeden Brothers, LLC | 70729-175 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-010 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-014 |
| Aspirin | Aspirin 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-011 |
| Acetaminophen | Acetaminophen 325 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-012 |
| Apapacetaminophen | Acetaminophen 500 mg/1 | TabletOral | Advance Pharmaceutical Inc. | 17714-013 |
Showing 20 of 37.