PANADOL
- Product NDC
- 0135-0537
- 11-digit product format
- 001350537
- Labeler code
- 0135
- Product ID
- 0135-0537_10c0504e-269e-b058-e063-6394a90a5b84
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-10-15
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0135-0537 | 0135-0537-02 | D | Discontinued by firm | 2026-10-16 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PANADOL
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e1799765-c247-42b4-ad6a-8ba7d136abf2 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0537-01 | PANADOL | 15 mL in 1 BOTTLE | SUSPENSION | 15 | 14 | |
| 0135-0537-01 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-02 | PANADOL | 54.7 mL in 1 BOTTLE | SUSPENSION | 54.7 | 14 | |
| 0135-0537-02 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-03 | PANADOL | 1 in 1 CARTON | SUSPENSION | 1 | 14 | |
| 0135-0537-03 | PANADOL | 118 mL in 1 BOTTLE | SUSPENSION | 118 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0537-03 | ML - Milliliter | 0135-0537 | 4d37b28e-b7a6-4ed1-a89f-c37b76e475d4 | 1 | 2022-12-07 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Pain Reliever | ACETAMINOPHEN | HHH Pharmaceuticals | 0c66b05d-132d-4c79-abfe-415fd68bbb9c | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Better Living Brands, LLC | 5ebd04d8-52c7-4c72-a4c1-fc7fd488ea24 | 2026-05-06 | Warnings | M013 |
| Back and Body Extra Strength | ASPIRIN, CAFFEINE | Cardinal Health 110, LLC. DBA Leader | 519eb216-9fa6-4d60-a2a4-3310bdb5b4ab | 2026-05-06 | Warnings | M013 |
| Aspirin | ASPIRIN | Geiss, Destin & Dunn Inc. | b8f6e486-5332-4c46-ab6c-7de04c91c60b | 2026-05-06 | Warnings | M013 |
| MAX relief junior Grape | CHILDRENS ACETAMINOPHEN | ATLANTIC BIOLOGICALS CORP. | c60494f0-5a50-41da-bcb4-88178ded54b7 | 2026-05-05 | Warnings | M013 |
| equate pain relief pm | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | WALMART INC. | 85129749-c1a7-4c4a-933f-c3c4768e2cdd | 2026-05-05 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | ARMY AND AIR FORCE EXCHANGE SERVICE | f3feca65-adc1-469f-bef6-12c860599abe | 2026-05-04 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Strategic Sourcing Services LLC | 4dda3534-4e83-447b-be75-33dadce06c47 | 2026-05-04 | Warnings | M013 |
| Aspirin Low Dose Chewable Orange | ASPIRIN | Major Pharmaceuticals | 4ba6eed3-004a-4576-b7f7-685fae49cf6a | 2026-05-04 | Warnings | M013 |
| Back and Body | ASPIRIN, CAFFEINE | Kroger Company | 366b58db-1ac3-427b-b42a-5f56a14e298c | 2026-05-01 | Warnings | M013 |
| Tylenol PM | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8ed9a9f0-d37e-5c10-e053-2a95a90a559f | 2026-05-01 | Warnings | M013 |
| Tylenol Extra Strength | ACETAMINOPHEN | Savings Distributors LLC | 8ed90757-833e-f4d9-e053-2995a90a29db | 2026-05-01 | Warnings | M013 |
| Acetaminophen , Aspirin and Caffeine | ACETAMINOPHEN , ASPIRIN AND CAFFEINE | Softgel Healthcare Pvt Ltd | 4543e156-1deb-666e-e063-6394a90a719c | 2026-04-27 | Warnings | M013 |
| Acetaminophen , Caffeine and pyrilamine maleate | ACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATE | Softgel Healthcare Pvt Ltd | 45478958-ad86-4d87-e063-6394a90a3c45 | 2026-04-27 | Warnings | M013 |
| Medique at Home Aspirin | ASPIRIN | Sportpharm LLC | 0f2aa75e-534f-478b-811e-fb492b7af9bb | 2026-04-24 | Warnings | M013 |
| Medique at Home APAP Extra Strength | ACETAMINOPHEN 500 MG | Sportpharm LLC | cc280926-ad94-4017-a04a-b4315807eacb | 2026-04-24 | Warnings | M013 |
| Aspirin | ASPIRIN | Health Pharma USA LLC | 503868bb-48e0-b718-e063-6394a90a9c5b | 2026-04-24 | Warnings | M013 |
| BC CHERRY | ASPIRIN AND CAFFEINE | Medtech Products Inc. | c5fa6660-a549-49ff-ac2b-5799afa22ec5 | 2026-04-24 | Warnings | M013 |
| Doans Maximum Strength | MAGNESIUM SALICYLATE | Dr. Reddy's Laboratories Inc. | c906df41-bb45-03ea-b1a8-2b9816d55c97 | 2026-04-24 | Warnings | M013 |
| Extra Strength Acetaminophen | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 48912649-9fa1-a11f-e063-6294a90a8a72 | 2026-04-23 | Warnings | M013 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0537-01 | 00135053701 | 1 BOTTLE in 1 CARTON (0135-0537-01) / 15 mL in 1 BOTTLE | 1 bottle | 2012-10-15 | 0000-00-00 | No | No | Current |
| 0135-0537-02 | 00135053702 | 54.7 mL in 1 BOTTLE | 54.7 ml | Historical | ||||
| 0135-0537-03 | 00135053703 | 1 BOTTLE in 1 CARTON (0135-0537-03) / 118 mL in 1 BOTTLE | 1 bottle | 2012-10-15 | 0000-00-00 | No | No | Current |