good sense nighttime sleep aid
- Product NDC
- 0113-0431
- 11-digit product format
- 001130431
- Labeler code
- 0113
- Product ID
- 0113-0431_70250c98-1eb2-4522-bdc6-7ce5a1468fda
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- M010
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-04-25
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 25 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
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 | 0113-0431 | 0113-0431-68 | D | Discontinued by firm | 2026-10-12 |
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
- good sense nighttime sleep aid
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| TC2D6JAD40 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1049630 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 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 |
|---|---|---|---|---|---|
| 0113-0431-62 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-68 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
| 0113-0431-78 | 2024-01-30 | C162847 | 48780-1 | 1030e365-0a5b-111a-e063-dadaa90a10e2 | Perrigo Nighttime Sleep Aid Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0113-0431-62 | good sense nighttime sleep aid | 12 in 1 CARTON | TABLET, FILM COATED | 12 | 5 | |
| 0113-0431-62 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 2 in 1 BLISTER PACK | TABLET, FILM COATED | 2 | 5 | |
| 0113-0431-68 | good sense nighttime sleep aid | 18 in 1 CARTON | TABLET, FILM COATED | 18 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 5 | |
| 0113-0431-78 | good sense nighttime sleep aid | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0431-62 | EA - Each | 0113-0431 | 9649502f-c6fa-4d7d-a6f7-a5202e5cda0e | 1 | 2012-07-24 |
| 0113-0431-78 | EA - Each | 0113-0431 | f5f22766-f73c-453c-bdb9-0283651b8829 | 1 | 2024-02-14 |
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 |
|---|---|---|---|---|---|---|
| Sleep Aid | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. DBA Leader | 1d73e966-aa4a-40a0-b42a-fda8e500756e | 2026-03-13 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Walgreens | ea1b5ec1-3c8e-437d-8e37-f38ab66d9f78 | 2026-03-13 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20 | 2026-03-11 | Warnings | M010 |
| sleep aid | DIPHENHYDRAMINE HCL | Rite Aid Corporation | bdfd7d87-2b54-4c29-ba69-aad0fab682e7 | 2026-03-11 | Warnings | M010 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Wal-Mart Stores Inc | 5ef35ab9-b6e8-4c88-a623-35ac9d6bd359 | 2026-03-05 | Warnings | M010 |
| Sleep-Aid | DIPHENHYDRAMINE HCL | WALMART INC. (see also Equate) | 84c37f4d-60f6-490e-ba8b-47d1257fa6f8 | 2026-02-13 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | P & L Development, LLC | 59c063ad-6ea3-4f1d-a20e-5e5e062a9098 | 2026-02-10 | Warnings | M010 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | f446e56f-c664-4092-8712-aa3f204172f8 | 2026-02-02 | Warnings | M010 |
| Sleep Aid Night Time | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | d805fab3-9dca-497f-bdc6-c8a7b1736109 | 2026-01-27 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 0e45d0e8-3741-7cee-e063-6394a90a2de5 | 2026-01-27 | Warnings | M010 |
| DIPHENHYDRAMINE HYDROCHLORIDE | DIPHENHYDRAMINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 335b09c6-ee5d-ebdf-e063-6294a90abd12 | 2026-01-27 | Warnings | M010 |
| Diphenhydramine hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 32033991-a4f0-f767-e063-6394a90a0b06 | 2026-01-27 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Wal-Mart Stores Inc | 90506598-046f-48d3-b8f5-d6ead0333812 | 2026-01-27 | Warnings | M010 |
| DORMMY-LON | DIPHENHYDRAMINE HYDROCHLORIDE | Haendel Farma, S.A. de C.V. | 562db961-83cb-4b74-9f34-fecee2c1be17 | 2026-01-27 | Warnings | M010 |
| Sleep Aid Nighttime | DIPHENHYDRAMINE HCL | Better Living Brands, LLC | dec955d3-817d-454f-b146-9a631e908dbc | 2026-01-27 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | Prodose, Inc. | c4bc3efd-8ca8-22fe-e053-2a95a90aed45 | 2026-01-26 | Warnings | M010 |
| NIGHTTIME SLEEP AID | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | f000d0b5-8ee8-4db0-99fe-aae5ed20c98e | 2026-01-19 | Warnings | M010 |
| Unisom SleepMinis Nighttime Sleep-Aid | DIPHENHYDRAMINE HCL | Chattem, Inc. | a9a44c2f-65eb-4a5a-9e72-43652dce57f7 | 2026-01-14 | Warnings | M010 |
| Unisom SleepMelts Nighttime Sleep-Aid | DIPHENHYDRAMINE HYDROCHLORIDE | Chattem, Inc. | 9105f4f1-7f94-408d-a025-83afb68dc9f0 | 2026-01-14 | Warnings | M010 |
| Rest Simply | DIPHENHYDRAMINE HYDROCHLORIDE | HYVEE INC | 462ca6cd-8eec-09df-e063-6294a90ac880 | 2026-01-13 | Warnings | M010 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1049630 | diphenhydrAMINE HCl 25 MG Oral Tablet | PSN | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
| 1049630 | diphenhydramine hydrochloride 25 MG Oral Tablet | SCD | ba2adc30-0301-4d53-bce6-fc8b7e34b076 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0431-62 | 00113043162 | 12 BLISTER PACK in 1 CARTON (0113-0431-62) / 2 TABLET, FILM COATED in 1 BLISTER PACK | 12 blister pack | 2001-04-25 | 0000-00-00 | No | No | Current |
| 0113-0431-68 | 00113043168 | 18 BLISTER PACK in 1 CARTON (0113-0431-68) > 2 TABLET, FILM COATED in 1 BLISTER PACK | 18 blister pack | 2019-05-21 | 0000-00-00 | No | No | Current |
| 0113-0431-78 | 00113043178 | 1 BOTTLE in 1 CARTON (0113-0431-78) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-12-29 | 0000-00-00 | No | No | Current |