Extra Strength NiteTime Pain Relief
- Product NDC
- 0363-0714
- 11-digit product format
- 003630714
- Labeler code
- 0363
- Product ID
- 0363-0714_3ac05a52-7cce-2bfb-e063-6394a90a134b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen 500 mg,Diphenhydramine Hydrochloride 25 mg Tablet
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- WALGREENS
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-10-12
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
- Active strength
- 25; 500 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0363-0714-42 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0363-0714-42 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0363-0714-42 | 0efc9e666f02… | f202fb6c5f17… |
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
- Extra Strength NiteTime Pain Relief
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1092189 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c25c75c7-157f-1c0d-e053-2995a90a2e3c | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0363-0714-42 | 2025-02-07 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
| 0363-0714-42 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-9e80-d83d-e063-dadaa90ab31f | 430R Walgreens Acetaminophen Diphenhydramine 500 mg/25 mg Caplets-24 counts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 24 in 1 BOTTLE | TABLET | 24 | 5 | |
| 0363-0714-42 | Extra Strength NiteTime Pain Relief | 1 in 1 CARTON | TABLET | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0363-0714 | EXTRA STRENGTH NITETIME PAIN RELIEF (ACETAMINOPHEN 500 MG,DIPHENHYDRAMINE HYDROCHLORIDE 25 MG TABLET) TABLET [WALGREENS] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250210_c25c75c7-157f-1c0d-e053-2995a90a2e3c.zip |
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 |
|---|---|---|---|---|---|---|
| Aspirin Low Dose | ASPIRIN | Sam's West Inc | 3b84746f-05ab-4f88-b9ae-efb8c5dfc233 | 2025-11-15 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | Walgreen Company | a482e715-bec0-44a4-bb0e-ea5f5fda558e | 2025-11-15 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f1157dbc-d86c-4554-954c-60a74674ff6b | 2025-11-15 | Warnings | M013 |
| Acetaminophen, Aspirin, Caffeine | ACETAMINOPHEN, ASPIRIN, CAFFEINE | NuCare Pharmaceuticals,Inc. | 437e4fd9-c7d9-77d6-e063-6294a90a22b7 | 2025-11-13 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 7f78028a-484b-48b3-a37a-1e0b055bbefc | 2025-11-13 | Warnings | M013 |
| OneSsip Acetaminophen | ACETAMINOPHEN | MEDWISE LIFESCIENCES INC. | 3f88de0f-6cf6-3580-e063-6294a90abcb4 | 2025-11-12 | Warnings | M013 |
| Tylenol PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE | Navajo Manufacturing Company Inc. | 435b1a31-353d-af20-e063-6294a90aa907 | 2025-11-11 | Warnings | M013 |
| Good Neighbor Pharmacy Pain Relief | ACETAMINOPHEN | Amerisource Bergen | 4b829607-f5fb-427f-83b5-5b6b9c44ebeb | 2025-11-11 | Warnings | M013 |
| Pamprin Max Menstrual Pain Relief | ACETAMINOPHEN AND ASPIRIN AND CAFFEINE | Focus Consumer Healthcare, LLC | 5bd4b935-f003-7df8-e053-2a91aa0a5d79 | 2025-11-10 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Shield Pharmaceuticals Corp | 61e50135-a7c2-4a86-8a1a-d47b41d3f9d1 | 2025-11-07 | Warnings | M013 |
| Childrens Chewables | ACETAMINOPHEN | Strategic Sourcing Services LLC | af2cbbaf-9b73-440a-bc88-a790cafccc6b | 2025-11-07 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | L.N.K. International, Inc. | 39e142a7-8590-4e1e-8319-6904fb57cc8a | 2025-11-06 | Warnings | M013 |
| TYLENOL Extra Strength | ACETAMINOPHEN | Kenvue Brands LLC | 42321456-d7dd-3b51-e063-6394a90ac292 | 2025-11-05 | Warnings | M013 |
| Childrens Pain Relief | ACETAMINOPHEN | Family Dollar Services Inc | 76058eb3-2d3f-4414-87df-7167cd27d26b | 2025-11-05 | Warnings | M013 |
| Children Pain and Fever Reliver | ACETAMINOPHEN | Target Corporation | 1116f808-f61e-47ec-b0d0-d4be5aa905be | 2025-11-04 | Warnings | M013 |
| Pain Reliever Dye Free | ACETAMINOPHEN | TIME CAP LABORATORIES, INC. | 42c4f0b2-6483-0f3c-e063-6294a90a140f | 2025-11-04 | Warnings | M013 |
| Headache Relief | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walmart Inc. | 1557bd9b-3e7c-4769-e063-6394a90a9d91 | 2025-11-04 | Warnings | M013 |
| Adult Low Dose Aspirin | ASPIRIN | Rising Pharma Holdings, Inc. | c3c4854e-726e-4926-b044-a5094943c306 | 2025-11-04 | Warnings | M013 |
| Pain Relief | ACETAMINOPHEN | HYVEE INC | 3e50b3f6-1e1a-41b9-e063-6394a90abe36 | 2025-11-03 | Warnings | M013 |
| Good Sense Pain Relief | ACETAMINOPHEN | L. Perrigo Company | 447de441-7d28-4415-81c5-4fc05622dd05 | 2025-11-03 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | c25c75c7-157f-1c0d-e053-2995a90a2e3c | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0363-0714-42 | 00363071442 | 1 BOTTLE in 1 CARTON (0363-0714-42) / 24 TABLET in 1 BOTTLE | 1 bottle | 2021-10-12 | 0000-00-00 | No | No | Current |