What is NDC 36800-369?

36800-369 is the product NDC for Topcare 8 Hour Pain Relief (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Topcare 8 Hour Pain Relief (Acetaminophen).

Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Topcare 8 Hour Pain Relief?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Topcare 8 Hour Pain Relief NDC 36800-369

NDC codes

FDA NDC Directory

Product NDC (as listed)36800-369Labeler and product segments. Claims need a package NDC.

Product NDC at billing width36800-0369Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
36800-369-78	3680003697836800036978	1 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLEMarketed from Apr 5, 2017

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): Topcare 8 Hour Pain Relief
Generic name (nonproprietary): acetaminophen
Active ingredients: Acetaminophen — 650 mg/1
Dosage form: Tablet, Film coated, Extended release
Route: Oral
Labeler: Topco Associates LLCNDC labeler code 36800
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075077
Marketing start: Apr 5, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17SPL ID c2db19bf-4ebf-4cd8-a6fd-892b50938f17SPL set ID 38abe710-3d8a-41b0-b057-38c5dfd53322RxCUI 1148399UNII 362O9ITL9D

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

N436800036978 followed by a unit qualifier and the quantity

Package 36800-0369-78. 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 May 13, 2025.

Indications (excerpt from the label)

Uses • temporarily relieves minor aches and pains due to: • muscular aches • backache • minor pain of arthritis • toothache • premenstrual and menstrual cramps • headache • the common cold • temporarily reduces fever

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 36800-369

What is NDC 36800-369?: 36800-369 is the product NDC for Topcare 8 Hour Pain Relief (acetaminophen), Acetaminophen 650 mg/1 tablet, film coated, extended release, listed with the FDA by Topco Associates LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Topcare 8 Hour Pain Relief (Acetaminophen).
What is the active ingredient?: Acetaminophen.
Who is the labeler?: Topco Associates LLC, NDC labeler code 36800. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Topcare 8 Hour Pain Relief?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under ANDA 075077

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075077
Product	Strength	Form · route	Labeler	Product NDC
DG Health 8 Hour Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Dolgencorp Inc	55910-749
Medlineacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Medline Industries, LP	53329-221
Good Sense Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-0044
equate 8hr arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	WALMART INC.	79903-345
Care One arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	American Sales Company	41520-544
Acetaminophen 650mgacetaminophen	Acetaminophen 650 mg/1	TabletOral	Forreal Pharmaceuticals, LLC	81877-850
topcare 8 hr arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Topco Associates LLC	36800-455
Leader 8HR Arthritis Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Cardinal Health 110, LLC. dba Leader	70000-0736
acetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Amazon.com Services LLC	72288-150
8 hr arthritis painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	51316-504
arthritis pain relieveracetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Walgreen Company	0363-0544
Equate Menstrual Pain Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	WALMART INC.	79903-420
dg health 8 hr arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Dolgencorp Inc	55910-828
Midol Long Lasting Reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Extended releaseOral	Bayer HealthCare LLC.	0280-8090
good sense pain relief arthritis painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Bryant Ranch Prepack	71335-2545
major acetaminophenacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Major Pharmaceuticals	0904-6883
Members Mark Arthritis Painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Sam's West Inc	68196-611
good sense pain relief arthritis painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	L. Perrigo Company	0113-0544
arthritis pain reliefacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	Publix Super Markets Inc	56062-544
good sense pain relief arthritis painacetaminophen	Acetaminophen 650 mg/1	Tablet, Film coated, Extended releaseOral	ASCLEMED USA INC.	76420-590

Showing 20 of 26.

Topcare 8 Hour Pain Relief (Acetaminophen) NDC 36800-369