Nighttime Sleep Aid
- Product NDC
- 69732-005
- Requested package NDC
- 69732-005-01
- 11-digit product format
- 697320005
- Labeler code
- 69732
- Product ID
- 69732-005_55f8f71f-4c2c-6161-e063-6394a90a6a8e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- acetaminophen, diphenhydramine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Hi-Tech Nutraceuticals, LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-04-30
- 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
- 2027-12-31
- 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 | 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… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 1332a3947898… | d4bfe170f9cd… |
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
- Nighttime Sleep Aid
- Listing expiration
- 2027-12-31
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 |
|---|---|
| a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 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 |
|---|---|---|---|---|---|
| 69732-005-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1698-111a-e063-dadaa90a10e2 | Sleep Aid |
| 69732-005-01 | 2024-01-30 | C162847 | 48780-1 | 1030e365-1698-111a-e063-dadaa90a10e2 | Sleep Aid |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69732-005-01 | Nighttime Sleep Aid | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | 3 |
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 |
|---|---|---|---|---|---|---|
| Aspirin 81 mg Low Dose | ASPIRIN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 23b29044-6389-42ea-839a-5351557a6ce3 | 2026-04-23 | Warnings | M013 |
| Childrens Pain and Fever | ACETAMINOPHEN | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 4a70867e-481d-4f01-9da3-d85663a1672e | 2026-04-23 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | United Natural Foods, Inc. dba UNFI | 07edcb31-d31d-4607-98c3-dcb1e062cc70 | 2026-04-22 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | ee50c5ee-1a61-4efc-aca9-42d897d6a3b8 | 2026-04-22 | Warnings | M013 |
| Aspirin | ASPIRIN | CVS PHARMACY | 904a2b21-d911-40c3-9e4b-59543ea5be4f | 2026-04-22 | Warnings | M013 |
| Pamprin Multi-Symptom Maximum Strength | ACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATE | Focus Consumer Healthcare, LLC | 60b3286d-5698-df50-e053-2991aa0afbe2 | 2026-04-20 | Warnings | M013 |
| Acetaminophen Extra Strength | ACETAMINOPHEN | CVS PHARMACY | af6fe4a9-2d18-4fed-b952-0a7866f65251 | 2026-04-20 | Warnings | M013 |
| Aspirin 81 mg | ASPIRIN | Preferred Pharmaceuticals Inc. | ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e | 2026-04-20 | Warnings | M013 |
| Parry-500mg Acetaminophen | ACETAMINOPHEN | MDC PHARMACEUTICALS LIMITED | fb07ba10-3210-41bc-9310-c952118fdcf3 | 2026-04-17 | Warnings | M013 |
| Aspirin NSAID | ASPIRIN | Valu Merchandisers Company | 0cc46a81-54c9-44b7-b384-79d25255eff2 | 2026-04-17 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN AND CAFFEINE | Valu Merchandisers Company | 99de2c41-59b0-42e7-847e-e51229c6164f | 2026-04-17 | Warnings | M013 |
| Pain and Fever Childrens | ACETAMINOPHEN | Walgreen Company | 1f3e2895-5ef7-4e6a-8d2e-b805d148f980 | 2026-04-16 | Warnings | M013 |
| Childrens TYLENOL | ACETAMINOPHEN | Kenvue Brands LLC | b297aff8-a08b-4d37-b168-800a56564cbd | 2026-04-16 | Warnings | M013 |
| Childrens Tylenol | ACETAMINOPHEN | Kenvue Brands LLC | 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3 | 2026-04-16 | Warnings | M013 |
| Pain Relief PM Extra Strength | ACETAMINOPHEN AND DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | 8e65478b-7a7b-416c-b8e3-23dad79f8cc1 | 2026-04-16 | Warnings | M013 |
| Aspirin Low Dose | ASPIRIN | Valu Merchandisers Company | c9e384e5-fa9b-4c75-b5e3-16eb8db662ef | 2026-04-16 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Preferred Pharmaceuticals Inc. | b6abfbbb-9826-4cd6-940f-3a314480a5a5 | 2026-04-15 | Warnings | M013 |
| Good Sense Pain and Fever | ACETAMINOPHEN | L. Perrigo Company | f7137fe6-582e-43a4-8302-90ca54cd1de3 | 2026-04-14 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | Cardinal Health 107, LLC | e13656eb-513e-411e-bdae-35ff1ba7cfc1 | 2026-04-13 | Warnings | M013 |
| CareOne Acetaminophen | ACETAMINOPHEN | American Sales Company | b4f54465-3232-4685-9570-90be00876577 | 2026-04-12 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1092189 | acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
| 1092189 | acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
| 1092189 | APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet | SY | a39e2bd6-3d0a-642b-e053-2995a90a42a0 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69732-005-01 | 69732000501 | 30 TABLET in 1 BOTTLE, PLASTIC (69732-005-01) | 30 tablet | 2020-04-30 | 0000-00-00 | No | No | Current |