Over-the-counter drug · OTC MONOGRAPH DRUG
Acetaminophen Diphenhydramine HCl NDC 69848-014
Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 · Tablet · Oral · Granules USA, Inc.
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69848-014Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69848-0014Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69848-014-02 | 6984800140269848001402 | 20 TABLET in 1 BOTTLE (69848-014-02)Marketed from Jul 1, 2019 | |
| 69848-014-05 | 6984800140569848001405 | 50 TABLET in 1 BOTTLE (69848-014-05)Marketed from Jul 1, 2019 | |
| 69848-014-15 | 6984800141569848001415 | 150 TABLET in 1 BOTTLE (69848-014-15)Marketed from Jul 1, 2019 |
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
- Diphenhydramine hydrochloride — 25 mg/1Acetaminophen — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Granules USA, Inc.NDC labeler code 69848
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 013
- Marketing start
- Listing expires
- Other FDA classes
- Histamine H1 Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 69848-014_4690f59f-4424-6231-e063-6294a90a8ca7SPL ID 4690f59f-4424-6231-e063-6294a90a8ca7SPL set ID 8c9f68e3-fedc-6457-e053-2995a90a045aRxCUI 1092189UNII TC2D6JAD40, 362O9ITL9D
- 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
N469848001402followed by a unit qualifier and the quantityPackage 69848-0014-02. 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.
About NDC 69848-014
- What is NDC 69848-014?
- 69848-014 is the product NDC for Acetaminophen Diphenhydramine HCl, Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 tablet, listed with the FDA by Granules USA, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Acetaminophen Diphenhydramine HCl.
- What is the active ingredient?
- Diphenhydramine hydrochloride, Acetaminophen.
- Who is the labeler?
- Granules USA, Inc., NDC labeler code 69848. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Acetaminophen Diphenhydramine HCl?
- 7 other product NDCs are listed under this name. See all Acetaminophen Diphenhydramine HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Acetaminophen Diphenhydramine HCl products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc. | 75907-431 | 75907-0431-0175907-0431-30 |
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Walgreens | 0363-9661 | 00363-9661-1500363-9661-25 |
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALGREEN CO. | 0363-9799 | 00363-9799-75 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | BETTER LIVING BRANDS LLC. | 21130-354 | 21130-0354-0221130-0354-08 |
| Acetaminophen Diphenhydramine HCL | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | WALGREENS CO. | 0363-9664 | 00363-9664-3700363-9664-60 |
| Acetaminophen, Diphenhydramine HCl | Diphenhydramine hydrochloride 25 mg/1; Acetaminophen 500 mg/1 | Tablet, Film coatedOral | CVS Pharmacy, Inc. | 69842-572 | 69842-0572-0269842-0572-0869842-0572-12 |
| Acetaminophen Diphenhydramine HCl | Acetaminophen 500 mg/1; Diphenhydramine 25 mg/1 | TabletOral | Chain Drug Consortium,LLC | 68016-654 | 68016-0654-0568016-0654-10 |
Other NDCs under M 013
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 |
|---|---|---|---|---|
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Grocery Outlet, Inc. | 85828-922 |
| Pain Relief Regular Strengthacetaminophen | Acetaminophen 325 mg/1 | TabletOral | CHAIN DRUG MARKETING ASSOCIATION INC | 83324-076 |
| equate pain and fever childrensacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Wal-Mart Stores Inc | 49035-042 |
| good neighbor pharmacy childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amerisource Bergen | 46122-210 |
| Aspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | GOODSENSE | 50804-880 |
| Tylenol PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Morning Star OTC | 53209-1002 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7897 |
| Headache Formula Extra Strengthacetaminophen, aspirin, caffeine | Acetaminophen 250 mg/1 + 2 more ingredients | Tablet, Film coatedOral | ARMY AND AIR FORCE EXCHANGE SERVICE | 55301-334 |
| childrens pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Walgreen Company | 0363-1239 |
| Tylenol PMacetaminophen, diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, Film coatedOral | Savings Distributors LLC | 73097-013 |
| Alka-Seltzer Originalanhydrous citric acid, aspirin, and sodium bicarbonate | Anhydrous citric acid 1000 mg/1 + 2 more ingredients | Tablet, EffervescentOral | Bayer HealthCare LLC. | 0280-4000 |
| Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Strategic Sourcing Services LLC | 70677-1260 |
| basic care infants pain and feveracetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Amazon.com Services LLC | 72288-946 |
| Acetaminophen | Acetaminophen 500 mg/1 | TabletOral | Sportpharm LLC | 85766-223 |
| Pain Relief Aspirin Low Doseaspirin | Aspirin 81 mg/1 | Tablet, Delayed releaseOral | Rite Aid Corporation | 11822-0600 |
| Equaline Effervescent Antacid and Pain Reliefaspirin, citric acid, sodium bicarbonate | Aspirin 325 mg/1 + 2 more ingredients | Tablet, EffervescentOral | United Natural Foods, Inc. dba UNFI | 41163-421 |
| Night Time Severe Cold and Cough Reliefacetaminophen, diphenhydramine hcl, phenylephrine hcl | Acetaminophen 325 mg/15mL + 2 more ingredients | LiquidOral | Chain Drug Consortium, LLC | 68016-154 |
| Tension Headache Relief | Acetaminophen 500 mg/1; Caffeine 65 mg/1 | Capsule, CoatedOral | Allegiant Health | 69168-001 |
| Childrens Acetaminophenacetaminophen | Acetaminophen 160 mg/5mL | SuspensionOral | Proficient Rx LP | 71205-263 |
| Chewable Aspirinaspirin | Aspirin 81 mg/1 | Tablet, ChewableOral | Chain Drug Marketing Association, Inc. | 83324-075 |
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