Over-the-counter drug · OTC MONOGRAPH DRUG
Pain Relief PM Extra Strength NDC 69168-393
acetaminophen 500 mg and diphenhydramine hcl 25 mg · Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 · Tablet · Oral · Allegiant Health
NDC codes
FDA NDC DirectoryProduct NDC (as listed)69168-393Labeler and product segments. Claims need a package NDC.
Product NDC at billing width69168-0393Add the package segment from the table below.
| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69168-393-02 | 6916803930269168039302 | 150 TABLET in 1 BOTTLE (69168-393-02)Marketed from Dec 23, 2014 | |
| 69168-393-24 | 6916803932469168039324 | 1 BOTTLE in 1 CARTON (69168-393-24) / 24 TABLET in 1 BOTTLEMarketed from Dec 23, 2014 | |
| 69168-393-26 | 6916803932669168039326 | 1 BOTTLE in 1 CARTON (69168-393-26) / 20 TABLET in 1 BOTTLEMarketed from Dec 15, 2021 | |
| 69168-393-50 | 6916803935069168039350 | 1 BOTTLE in 1 CARTON (69168-393-50) / 50 TABLET in 1 BOTTLEMarketed from Dec 23, 2014 | |
| 69168-393-99 | 6916803939969168039399 | 365 TABLET in 1 BOTTLE (69168-393-99)Marketed from Dec 23, 2014 |
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)
- Pain Relief PM Extra StrengthSuffix: Extra Strength
- Generic name (nonproprietary)
- acetaminophen 500 mg and diphenhydramine hcl 25 mg
- Active ingredients
- Acetaminophen — 500 mg/1Diphenhydramine hydrochloride — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Allegiant HealthNDC labeler code 69168
- 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 69168-393_d525d4d3-adac-40fb-a927-832f7d6a831bSPL ID d525d4d3-adac-40fb-a927-832f7d6a831bSPL set ID 423a8445-964c-4cdb-889a-f391ca5253e7RxCUI 1092189UNII 362O9ITL9D, TC2D6JAD40UPC 0369168267992
- 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
N469168039302followed by a unit qualifier and the quantityPackage 69168-0393-02. 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 temporarily relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Excerpt only. Read the full label for complete information.
About NDC 69168-393
- What is NDC 69168-393?
- 69168-393 is the product NDC for Pain Relief PM Extra Strength, Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 tablet, listed with the FDA by Allegiant Health. It has 5 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pain Relief PM Extra Strength (Acetaminophen 500 mg and Diphenhydramine HCl 25 mg).
- What is the active ingredient?
- Acetaminophen, Diphenhydramine hydrochloride.
- Who is the labeler?
- Allegiant Health, NDC labeler code 69168. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pain Relief PM Extra Strength?
- 12 other product NDCs are listed under this name. See all Pain Relief PM Extra Strength NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pain Relief PM Extra Strength products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | CHAIN DRUG MARKETING ASSOCIATION, INC. | 83324-085 | 83324-0085-0183324-0085-50 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-195 | 68998-0195-02 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | MARC GLASSMAN, INC. | 68998-071 | 68998-0071-03 |
| Pain Relief PM Extra Strengthpain relief pm | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Allegiant Health | 69168-003 | 69168-0003-50 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | GoodSense | 50804-825 | 50804-0825-02 |
| Pain Relief PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | QUALITY CHOICE (Chain Drug Marketing Association) | 63868-119 | 63868-0119-50 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | HEB | 37808-795 | 37808-0795-03 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hydrochloride | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | TopCo Associates LLC | 36800-095 | 36800-0095-0336800-0095-17 |
| Pain Relief PM Extra Strengthacetaminophen, diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | H E B | 37808-556 | 37808-0556-0937808-0556-31 |
| Pain Relief PM Extra Strengthacetaminophen and diphenhydramine hcl | Acetaminophen 500 mg/1; Diphenhydramine hydrochloride 25 mg/1 | Tablet, CoatedOral | DOLGENCORP, LLC | 55910-655 | 55910-0655-1055910-0655-31 |
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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