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 | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | 318cc982-23a9-4804-b6fb-248f772d7a38 | 2026-04-02 | Warnings | M013 |
| Chewable Acetaminophen Childrens | ACETAMINOPHEN | Cardinal Health 110, LLC. DBA Leader | 8a18565c-b84e-43f8-8e96-e1dbcc39f08b | 2026-04-02 | Warnings | M013 |
| Childrens Pain Reliever | ACETAMINOPHEN | H E B | c713556c-cb9e-4ed2-bc2f-49b3d6256c0f | 2026-04-02 | Warnings | M013 |
| Aspirin | ASPIRIN | Discount Drug Mart | 4a1e9c79-5036-4c69-82f9-e48abc972b47 | 2026-04-02 | Warnings | M013 |
| Wispirin | ASPIRIN | Wisdrug AG | 4e70ec5e-d033-a525-e063-6394a90a5a93 | 2026-04-01 | Warnings | M013 |
| Aspirin Regimen | ASPIRIN | Cardinal Health 110, LLC. DBA Leader | ef2d75ee-9ed7-4b53-adbc-2ec40364da63 | 2026-03-31 | Warnings | M013 |
| Tension Headache Relief | ACETAMINOPHEN, CAFFEINE | Hi-Tech Nutraceuticals, LLC | b119ba37-0ee3-851a-e053-2995a90a85b1 | 2026-03-31 | Warnings | M013 |
| Aspirin | ASPIRIN | RMT HEALTH LLC | 4dc7229d-c895-1f80-e063-6394a90abfc3 | 2026-03-30 | Warnings | M013 |
| Aspirin | ASPIRIN | PD-Rx Pharmaceuticals, Inc. | d1f05e56-c830-4f85-b685-2a5965d10a1c | 2026-03-26 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Bryant Ranch Prepack | ad01aea6-4af3-469b-b99d-e1e66aa40e8d | 2026-03-25 | Warnings | M013 |
| aspirin | ASPIRIN | Meijer Distribution Inc | c550b92e-de54-4599-9534-bd3022b0a86d | 2026-03-25 | Warnings | M013 |
| Low Dose Aspirin | ASPIRIN | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | db187226-0770-4934-90a4-c6ca50bdecef | 2026-03-25 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | 804d4b63-1bbe-47c0-ad49-39ddbeade6a3 | 2026-03-25 | Warnings | M013 |
| childrens pain and fever | ACETAMINOPHEN | HyVee Inc | 9d9c2bf6-8660-4987-8794-936d3102da8d | 2026-03-24 | Warnings | M013 |
| Childrens Pain Reliever | ACETAMINOPHEN | BJWC (Berkley & Jensen / BJ's) | 851228ea-eaf3-452b-a9ce-8cd244a0eaf3 | 2026-03-24 | Warnings | M013 |
| FirstCare Childrens Pain Fever Acetaminophen | ACETAMINOPHEN 80 MG | USpharma Ltd | 9fc05ba6-5667-457e-82c1-a8b4e16cadda | 2026-03-23 | Warnings | M013 |
| Aspirin | ASPIRIN | Aarkish Pharmaceuticals NJ Inc. | e5e9e1ce-666a-461f-8287-a4642902067c | 2026-03-23 | Warnings | M013 |
| Chewable Aspirin Low Dose | CHEWABLE ASPIRIN | Grocery Outlet | 609c0389-8bed-4483-84fa-73ee73fdb4e4 | 2026-03-20 | Warnings | M013 |
| Adult Low Dose Pain Reliever | ASPIRIN | TWIN MED LLC | a395acf4-f487-4c98-8c44-ca2aaaf72deb | 2026-03-20 | Warnings | M013 |
| Rapidol | ACETAMINOPHEN | Pharmadel LLC | 3a210860-1fc1-e496-e063-6394a90a8705 | 2026-03-20 | 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 |